Baxter International Inc. announced today it has issued an Urgent Device Correction to reinforce important safety information regarding cleaning practices of all Spectrum infusion pumps distributed in the United States, Canada, and the Caribbean, as deviations from the specified cleaning methods may
Sunstar Americas, Inc. (SAI) is voluntarily recalling Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% products bearing an expiration date from 6/30/22 – 9/30/22 (see specific lots below) to the consumer level. This product may be contaminated with
the bacteria Burkholderia lata.
FDA is warning that use of NSAIDs around 20 weeks or later in pregnancy may cause rare but serious kidney problems in an unborn baby. This can lead to low levels of amniotic fluid surrounding the baby and possible complications.
FDA's recommendations to health care providers on giving instructions to patients who self-collect an anterior nares sample for SARS-CoV-2 testing.
Marksans Pharma Limited, India is voluntarily expanding its earlier initiated recall on June 05, 2020 to include an additional 76 unexpired lots of Metformin Hydrochloride Extended-Release Tablets, USP 500mg, & 750mg to the consumer level. Marksans performed N-Nitrosodimethylamine (NDMA) testing of
Becton Dickinson CareFusion 303, Inc. Recalls Alaris System Pump Module and Pump Module Door Assembly Replacement Kits Due to the Potential for Stuck or Unresponsive Keys
Ashtel Studios has announced a voluntary recall of all lots of licensed hand sanitizer packaged in .84 oz containers resembling food and drink pouches labeled with various children’s characters listed in the table below to the consumer level. The products are being recalled because they are packaged
Estado de México, México, DMM VISSION, S.A. de C.V. is voluntarily recalling five lots of Cleaner Hand Sanitizer, 500 mL and 1,200 mL plastic clear bottles with white tops currently in US distribution to the consumer level. This recall is being initiated out of abundance of caution due to detection
The FDA is providing new information about the risk of NTM infections in patients who have undergone cardiothoracic surgeries using heater-cooler devices.
Mammography Problems at Allison Breast Center at Monument Radiology
FDA is warning that taking higher than recommended doses of the common over-the-counter (OTC) allergy medicine Benadryl (diphenhydramine) can lead to serious heart problems, seizures, coma, or even death.
The FDA is providing recommendations for certain high-risk populations may be more vulnerable to potential adverse health effects of mercury exposure from dental amalgam.
The FDA is requiring the Boxed Warning be updated by adding other information to the prescribing information for all benzodiazepine medicines. This information will describe the risks of abuse, misuse, addiction, physical dependence, and withdrawal reactions across all the medicines in the class.
Sun Pharmaceutical Industries, Inc. (SUN PHARMA), a wholly owned subsidiary of Sun Pharmaceutical Industries Ltd. is voluntarily recalling one lot of RIOMET ER™ (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL to the consumer level. The reason for the recall is due to
Three of the recalls, which BD announced on Aug. 4, 2020, have been designated as Class I recalls by the U.S. Food and Drug Administration (FDA), which means that FDA has determined that there is a reasonable probability that the use of the product will cause serious adverse health consequences or d
Acella Pharmaceuticals, LLC is voluntarily recalling one lot of 15-mg and one lot of 120-mg NP Thyroid®, Thyroid Tablets, USP [levothyroxine (T4) and liothyronine (T3)] to the consumer level. The products are being recalled because testing has found these lots to be sub potent. The product may have
The Alaris System is an infusion system. If parts of the PCA or Syringe Modules are damaged, incorrect syringe details may show, leading to inaccurate infusions.
The Alaris System Infusion Pump is the foundation of the infusion system. Multiple models are being recalled due to damaged IUI Connectors, loose or missing Battery Screws and broken upper and lower hinge posts and membrane frame.
The Alaris System is an infusion system. The PC Unit Keys may become stuck or unresponsive and may lead to an infusion delay or prevent clinicians from changing fluid or medication infusions on the affected device.
Medek, LLC is voluntarily recalling all lots of M Hand Sanitizer Alcohol Antiseptic 80% 128 oz/3,785 mL to the consumer level. FDA analysis found the M Hand Sanitizer to contain methanol and be sub-potent for ethanol. Substantial methanol exposure can result in nausea, vomiting, headache, blurred v
The U.S. Food and Drug Administration (FDA) wants patients and health care providers to know about the risk of injury that may happen to patients if the cold-therapy mode of water-circulating hot/cold therapy devices is not used correctly.
The FDA has reviewed serious side effects associated with implanted spinal cord stimulators.
CorgioMed, LLC is voluntarily recalling all lots of Leafree Instant Hand Sanitizer-Aloe Vera, within expiry to the consumer level. The products are being recalled because they are labeled as “EDIBLE ALCOHOL”. Leafree Hand Sanitizer is an alcohol-based hand rub to be applied externally to reduce bac
Miami, Florida. AJR Trading is voluntarily recalling 2,004 units of lot 20DF8307 of bio aaa Advance Hand Sanitizer currently in US distribution, packaged in 480 mL bottles, to the consumer level. This lot of bio aaa Advance Hand Sanitizer has been tested and meets all appropriate specifications an
RLC Labs, Inc. is voluntarily recalling a total of 483 lots of Nature-Throid® and WP Thyroid® in all strengths, all counts of product within current expiry to the consumer level. The products are being recalled because testing of samples from six (6) lots by the U.S. Food and Drug Administration
The Protein Shoppe, LLC is voluntarily recalling all lots of “Red-E” (Male Enhancement tablet) to the consumer level. This recall has been initiated after an FDA laboratory analysis found the product to contain undeclared sildenafil, a Phosphodiesterase-5 (PDE-5) inhibitor which is the active ingred
BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today provided an update on a previously announced voluntary recall of the BD Alaris™ System. Three of the situations described in this recall, which BD announced on June 30, 2020, have been designated as Cl
Mylan N.V. (NASDAQ: MYL) today announced that its U.S.-based Mylan Institutional LLC business is conducting a voluntary nationwide recall to the hospital/clinic level of four lots of Amiodarone HCl Injection, USP 450 mg/9 mL, packaged in cartons of 10 single-dose 9 mL vials and Tranexamic Acid Injec
Gowns purchased from Laws of Motion have potential quality issues and should not be used as personal protective equipment.
Guadalupe, Nuevo Leon, Harmonic Nature is voluntarily recalling all 800 bottles Hand Sanitizer, 250mL, product due to the potential presence of 1-propanol. The products have been tested and found to contain 1 propanol. Any amount of 1-propanol with a concentration greater than or equal to 1% by v
Based on FDA's review of new data from three clinical trials, the Boxed Warning about amputation risk from the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) prescribing information was removed.
Apodaca, Nuevo Leon, Nanomateriales is voluntarily recalling all lots of ZANILAST+ GEL, Sanitizer gel, to the consumer level. FDA laboratory analysis found ZANILAST+ GEL to contain 1-propanol. There is a reasonable probability of acute toxicity from ingestion which can cause central nervous system
Mexico City, Mexico, Asiaticon SA de CV (Mexico) is voluntarily recalling all lots of V-Klean Hand Sanitizer Gel, Medically Minded Hand Sanitizer Gel and Protz Real Protection Antibacterial Hand Sanitizer sold in 13.5, 16.9 and 33.8 ounce bottles to the consumer level. The products are being recalle
Medfusion 3500 and 4000 syringe pumps control fluid and drug delivery to patients. A software issue may cause over- or under- delivery, causing adverse events.
The FDA is alerting health care providers and facilities that using protective barrier enclosures when treating COVID19 patients may pose increased health risks
Bayshore Pharmaceuticals, LLC, Short Hills, NJ is voluntarily recalling one (1) lot of Metformin Hydrochloride Extended-Release Tablets USP, 500 mg, 1000 count bottles and one (1) lot of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, 100 count bottles within expiry to the consumer lev
Grupo Asimex de Mexico SA de CV is voluntarily recalling all lots of FLORANCE MORRIS Antiseptic Hand Sanitizer, 70% Alcohol, packaged in 8 fl oz bottles and 1L bottles to the consumer level. The products have the potential to contain methanol (wood alcohol) and be sub-potent for the ethanol conte
Windsor, CT, SCA Pharmaceuticals (SCA) is voluntarily recalling 10 lots of Heparin Sodium to the hospital/user level. The compounded Heparin Sodium bag contains the undeclared preservative benzyl alcohol. The labelling listed methylparaben and propylparaben as preservatives; however, are not presen
Guadalupe, Nuevo León, Grupo Yacana México S.A.S de C.V. is voluntarily recalling All Lots of Yacana Hand Sanitizer, 70% Alcohol, 250 ml to the consumer level. The products have the potential to contain methanol (wood alcohol) and be sub-potent for the ethanol content.
SAN JUAN del RIO QUERETARO, Mexico -- ALBEK de Mexico S.A. de C.V. is voluntarily recalling all lots and all brands of hand sanitizer currently in US distribution to the consumer level. The products were manufactured between November 7, 2019 and June 28, 2020. This recall is being initiated out of
North Little Rock, AR, Maison Terre is voluntarily recalling all lots of its Goldenseal Root Powder, purchased from Starwest Botanicals, Sacramento, CA, and repackaged to the consumer level due to microbial contamination. FDA laboratory analysis of product samples found these products to be contami
The FDA is alerting clinical laboratory staff and health care providers of a risk of false results with Thermo Fisher Scientific TaqPath COVID-19 Combo Kit.
SG24 LLC is voluntarily recalling the SkinGuard24 – All Day Hand Sanitizer products listed below to the consumer level.
BD (Becton, Dickinson and Company), a leading global medical technology company, announced a voluntary recall on June 23, 2020 for specified catalog numbers of the ChloraPrep™ 3 mL applicator due to possible fungal contamination, which only affects climate zone IV regions in specific U.S. territorie
Soluciones Cosméticas voluntary recalled all lots of Bersih Hand Sanitizer Gel Fragrance Free sold in 16.9 ounce bottles to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol). This release provides additional information about the packaging f
Incredible products sa de cv issues voluntary nationwide recall of gelbac t antibacterial handgel due to potential presence of undeclared methanol (wood alcohol)
CME America BodyGuard® Infusion System Administration Sets because the pumps may have a slower than expected delivery of medication (under-infusion), or faster than expected delivery of medication (over-infusion) or a delay in therapy.
Ferring Pharmaceuticals US is voluntarily recalling all lots on the market of DDAVP® Nasal Spray 10 mcg/0.1mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1mL, and STIMATE® Nasal Spray 1.5 mg/mL listed in the table below to the consumer level. These products are being recalled due to superpotency or a
Roque Plast S.A. de C.V. is voluntarily recalling lots 200371-12, 200371OH-05, 170420OH-06, 170420OH-8 manufactured by Roque Plast S.A. de C.V. of Command Brands Gel AntiBac Instant Hand Sanitizer to the consumer level. This recall has been initiated due purported potential presence of methanol indi
LABORATORIOS JALOMA S.A. de C.V. is voluntarily recalling all lots and all bottle sizes of the Jaloma Antiseptic Hand Sanitizer, Ethyl Alcohol 62% With vitamin E to the consumer level. This recall has been initiated because FDA sampled the 500 mL product and found it to be contaminated with undeclar
Albek de Mexico S.A. de C.V is voluntarily recalling all lots and all brands of hand sanitizer currently in US distribution to the consumer level. This recall is being initiated out of an abundance of caution due to detection of methanol in hand sanitizer samples manufactured by Albek when product
The FDA has received several reports of patients with deep brain stimulators for Parkinson’s Disease experiencing loss of coordination during water-related activities requiring coordinated movements (e.g. swimming). Patients should exercise caution when bathing.
Broncolin S.A. de C.V is voluntarily recalling all lots of Herbacil Antiseptic Hand Sanitizer 70% Alcohol to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol).
San Antonio, Texas, 4e Brands North America is voluntarily recalling all lots of Hand Sanitizer brands to the consumer level. These products are being recalled due to the potential presence of methanol (wood alcohol).
RESOURCE RECOVERY & TRADING LLC, is voluntarily recalling all the lots manufactured by MXL Comercial S.A. de C.V. of Hand Sanitizer with the next information: HAND SANITIZER 70% Ethyl Alcohol Disinfectant Gel, packaged in 6.7 FL Oz. (200 ml) bottles, UPC 650240026020 and HAND SANITIZER Non-sterile S
Maquiladora Miniara S.A. de C.V. is voluntarily recalling lots of Shine and Clean Hand Sanitizer gel to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol) Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision,
La Loma, Tlalnepantla, Mexico, Real Clean Distribuciones SA de CV is voluntarily recalling all lots it manufactured within expiry of the following brand names of hand sanitizers: Substantial methanol exposure could result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures,
The FDA is requiring drug manufacturers for all opioid pain relievers and medicines to treat opioid use disorder to add new recommendations about naloxone to the prescribing information.
The FDA is reminding owners and operators about repair and maintenance of tanning beds and booths. Owners and operators of tanning beds and booths should perform maintenance recommended by product manufacturers to reduce risk of smoke and fire.
Fresenius Kabi USA is voluntarily recalling two lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg/50 mL (4 mcg / mL), 50 mL fill in a 50 mL vial. Fresenius Kabi initiated this recall due to the possibility of a trace amount of lidocaine present in these two lots and our investig
LIQ-E S.A. de C.V. is voluntarily recalling all lots and all bottle sizes of The OPTIMUS Instant Hand Sanitizer due to the potential presence of methanol (wood alcohol) that were shipped into the United States. The products were manufactured between April 27, 2020 and May 08, 2020.
InHe Manufacturing, LLC and MHR Brands Issues Voluntary Nationwide Recall of Several Products Due to Potential Health Risk for Excess Lead
The Core OneTouch Smart Cable is used to connect the GlideScope Spectrum Single-use video laryngoscopes and GlideScope Video Baton 2.0 (Large) to the Core 10 and Core 15 video monitors. If too much force is used to twists the cable to connect the blade in the HDMI port or to the connection port. The
The Core OneTouch Smart Cable is used to connect the GlideScope Spectrum Single-use video laryngoscopes and GlideScope Video Baton 2.0 (Large) to the Core 10 and Core 15 video monitors. If too much force is used to twists the cable to connect the blade in the HDMI port or to the connection port. The
AAA Cosmética, S.A. de C.V. is voluntarily recalling all lots of bio aaa Advance Hand Sanitizer currently in US distribution, packaged in 480 mL bottles, to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol).
Soluciones Cosméticas is voluntarily recalling all lots of Bersih Hand Sanitizer Gel Fragrance Free sold in 16.9 ounce bottles to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol).
4e Brands North America is voluntarily recalling ten (10) bottle sizes of Hand Sanitizers to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol)
Endologix® Inc. (Nasdaq: ELGX) (“Endologix” or the “Company”), a developer and marketer of innovative treatments for aortic disorders, today announced that a correction notice has been issued for the Ovation iX system, that identifies the root cause of polymer leaks. This voluntary action has been c
Lupin Pharmaceuticals Inc. is voluntarily recalling all batches of Metformin Hydrochloride Extended-Release Tablets USP, 500mg and 1000mg to the consumer level. As part of the ongoing assessment and continuation of the dialog with the FDA, additional analysis revealed that certain tested batches wer
As part of CME America's commitment to quality, following the previously announced recall (April 27, 2020) of the BodyGuard® Infusion Pump Systems, the company conducted additional flow-rate accuracy testing. This testing revealed that some infusion sets do not meet the ±5% delivery accuracy for the
Mylan N.V. (NASDAQ: MYL) today announced that its U.S.-based Mylan Institutional LLC business is conducting a voluntary nationwide recall to the consumer level of one lot of Daptomycin for Injection, 500 mg/vial due to the presence of particulate matter found in one single-dose vial manufactured b
FDA warns lab staff that use of BD SARS-CoV-2 Reagents for the BD Max System may lead to false positive results.
Granules Pharmaceuticals, Inc., Chantilly, VA is voluntarily recalling twelve (12) lots of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, 100 and 500 count bottles within expiry to the consumer level due to the detection of NNitrosodimethylamine (NDMA) levels above the Acceptable Dail
ITECH 361 is voluntarily recalling 18,940 bottles of All Clean Hand Sanitizer, Moisturizer and Disinfectant sold in one liter bottles to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol).
Arrow International is recalling the pumps because both devices have a part that may break, char, and discolor the motor connector wires.
Transliquid Technologies LLC is voluntarily recalling all Mystic Shield Protection Topical Solution, manufactured by Mystic Intl S.A. de C.V in Mexico City, and packaged in an 8.45 ounce (250 ml) bottles, to the consumer level.
UVT, INC. is voluntarily recalling 38,830 liters of SANIDERM ADVANCED HAND SANITIZER, packaged in 1-liter bottles to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol)
Saniderm Products (Saniderm) is voluntarily recalling Saniderm Advanced Hand Sanitizer, packaged in 1-liter bottles to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol). In response to a recent news alert by the Food and Drug Administration
On June 18, 2020, Chengdu Ai Qin E-commerce Co., Ltd initiated a nationwide recall of 1362 pairs of colored contact lenses. The relevant series of contact lenses have been found to be distributed without FDA clearance and may pose a threat to health.
FDA warns lab staff and health care providers about using certain COVID-19 Serology/Antibody Tests.
GSK Consumer Healthcare is voluntarily recalling to the retail level two lots (listed below) of Children’s Robitussin® Honey Cough and Chest Congestion DM and one lot of Children’s Dimetapp® Cold and Cough, due to the inclusion of incorrect dosing cups.
FDA is warning health care providers that co-administration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended as it may result in reduced antiviral activity of remdesivir.
Lupin Pharmaceuticals Inc. is voluntarily recalling Metformin Hydrochloride Extended-Release Tablets USP (generic equivalent of Fortamet®), 500mg, lot G901203 to the consumer level. FDA analysis revealed that this lot exceeded the Acceptable Daily Intake Limit for the impurity N-Nitrosodimethylamine
Teva Pharmaceuticals USA, Inc. is voluntarily recalling fourteen (14) lots of Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, 100 and 1000 count bottles, in the United States to the consumer-level due to the detection of N-Nitrosodimethylamine (NDMA) levels in excess of the
Marksans Pharma Limited, India is voluntarily recalling Metformin Hydrochloride Extended-Release Tablets, USP 500mg, lot # XP9004, to the consumer level. FDA analysis has found the product to contain N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI) of 96ng/da
FDA warns lab staff that exposure to cyanide gas may result from a reaction between transport media and testing platforms that are not compatible.
FDA is notifying health care professionals about the temporary absence of the “paralyzing agent” warning statement embossed on the vial caps of two neuromuscular blocking agents.
FDA is alerting the public to immediately inspect certain lots of Amneal and Impax epinephrine auto-injector 0.3 mg to ensure the yellow “stop collar” in the device is present.
FDA announces BIOCELL Textured Surface Allergan Breast Implants and Tissue Expanders Will No Longer Be Sold in the U.S.
Amneal Pharmaceuticals LLC Bridgewater, New Jersey (Amneal), is voluntarily recalling all lots of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, within expiry to the Retail Level.
Amneal was notified by the U.S. FDA that the Agency’s testing of seven lots of Metformin Hydr
StealthStation auto-registration feature helps guide surgeons to conduct deep brain stimulation (DBS) procedures. A software issue may lead surgeons to erroneously perform DBS procedures.
Allergan Aesthetics, an AbbVie company (NYSE: ABBV), is initiating a new digital campaign to improve device tracking and further identify and reach breast implant patients who have, or have had, BIOCELL® breast implants and/or tissue expanders to inform them of the risk of BIA-ALCL. Since Jul
These devices are parts of the The HeartWare Ventricular Assist System (HVAD). They attach to the HeartWare HVAD pump which helps the heart deliver blood to the rest of the body. The clamp screws are at risk of breaking when tightening the strain relief clamp and outflow graft tears have been observ
Apotex Corp is voluntarily recalling all lots of Metformin Hydrochloride Extended-Release Tablets, USP 500mg within expiry to retail level. Apotex was notified by the U.S. Food and Drug Administration (US FDA) that one lot of Metformin Hydrochloride Extended-Release Tablets, USP was tested and showe
The FDA is reminding reprocessing staff in health care facilities to use the correct decontamination cycle associated with certain models of the ASP STERRAD Sterilization Systems to decontaminate compatible NN95 respirators.
Acella Pharmaceuticals, LLC is voluntarily recalling a total of 13 lots of 30-mg, 60-mg and 90-mg NP Thyroid® (thyroid tablets, USP) to the consumer level. The products are being recalled because our testing has found these lots to be superpotent. The product may have up to 115.0% of the labeled amo
Biota Biosciences is voluntarily recalling the following lots in the table below of Cannabidiol (CBD) Complex, Curcumin Complex, and Cannabidiol + Curcumin Injectables to the customer level.
Summitt Labs is voluntarily recalling Batch#730 Lot#K018 of KORE ORGANIC Watermelon CBD Oil Tincture, 30 ml bottle, 15mg 450x to the consumer level. The Florida Department of Agriculture and Consumer Services tested a random sample and found the product to contain lead levels at 4.7 ppm.
The identified catheters are latex balloon catheters used for temporary blockage, closing of a blood vessel, or infusion of fluids. These catheters are at risk of tip detachment which could lead to pieces of the catheter breaking off. This could cause serious consequences.
MasterPharm, LLC. is voluntarily recalling 1 lot of Finasteride Plus 1.25mg, capsules to the consumer level. The Finasteride Plus capsules have been found to contain undeclared minoxidil, an antihypertensive drug, at levels greater than those found in FDA approved products. The undeclared minoxidil
ICU Medical, Inc. is voluntarily recalling one single lot of Lactated Ringer's Injection, USP. The products are being recalled to the hospital/user level due to the presence of particulate matter identified as iron oxide. ICU Medical became aware of this issue through a single customer complaint
3M Comply Hydrogen Peroxide Chemical Indicator 1248 and Aesculap MD334 Process Indicator Card use different colors to indicate a sterilized device.
The FDA is concerned that certain respirators from China may not provide adequate protection to health care personnel based on testing by CDC NIOSH.
Vascular Solutions, Inc. recalled the Langston Dual Lumen catheter due to the inner catheter may separate during or after a high-pressure injection.
CME America, a wholly owned subsidiary of BD (Becton, Dickinson and Company), a leading global medical technology company, today issued the following update regarding two previously announced voluntary recalls, one related to all models of CMEAmerica BodyGuard® infusion pumps (FDA Recall Number: Z-1
FDA continues to work with the manufacturers to evaluate reports of deaths in patients with liquid-filled intragastric balloon systems used to treat obesity.
The FDA is issuing this update to alert health care providers of five reports of unanticipated deaths that occurred from 2016 to present in patients with liquid-filled intragastric balloon systems used to treat obesity.
The FDA has recently received multiple reports for two different types of adverse events associated with liquid-filled intragastric balloons used to treat obesity. The first type of adverse event involves balloon over-inflating and the second type is development of acute pancreatitis.
The FDA recognizes that the need for personal protective equipment (PPE), such as surgical masks, surgical and isolation gowns, and surgical suits, may outpace the supply available to health care organization during the Coronavirus Disease 2019 (COVID-19) outbreak.
QuVa Pharma, Inc. confirms that is working with the U.S. Food and Drug Administration, and voluntarily recalling all lots of R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) 50 ml in Sodium Chloride-60 ml BD syringe that were prepared using sterile Ketorolac being recalled by Fresenius Kabi
An update on the potential risks of over-inflation (spontaneous hyperinflation), acute pancreatitis, and deaths in patients with Orbera and ReShape liquid-filled intragastric balloons used for weight loss in adult patients with obesity.
FDA is concerned that hydroxychloroquine and chloroquine are being used inappropriately to treat non-hospitalized patients for coronavirus disease (COVID-19) or to prevent that disease.
Trividia Health, Inc. today announced it is initiating a nationwide voluntary recall of one (1) TRUE METRIX® AIR Blood Glucose Meter distributed in the United States to one customer (AssuraMed). The meter was not packaged into storebrand or retail branded packaging.
Fresenius Kabi USA, LLC is voluntarily recalling 13 lots of Ketorolac Tromethamine Injection, USP, 30 mg/mL, 1 mL fill in a 2 mL amber vial and Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL fill in a 2 mL amber vial to the user level due to the presence of particulate matter
Braun Medical Inc. (B. Braun) is voluntarily recalling one (1) lot of 2g Ceftazidime for Injection USP (2g) and Dextrose for Injection USP (50 ml) in Duplex® Container to the hospital/user level.. During stability testing of Batch H8J812, test results were found to exceed the specification limits fo
The FDA recommends that health care providers continue to use serological tests intended to detect antibodies to SARS-CoV-2 to help identify people who may have been exposed to the SARS-CoV-2 virus or have recovered from the COVID-19 infection.
Avet Pharmaceuticals Inc. (“Avet”), based in East Brunswick, New Jersey, is initiating a voluntary recall of the following lots of Tetracycline HCl Capsules USP, 250 mg and 500 mg, 100-count bottles listed in the table below to the consumer/user level. These drug products are manufactured by Avet Ph
AuroMedics Pharma LLC is voluntarily recalling lot AFO l 17001-A, Expiry date Dec 2018, of Ampicillin and Sulbactam for Injection USP, 1.5 g (equivalent to 1 g ampicillin as the sodium salt plus 0.5 g Sulbactam as the sodium salt) in a Single-Dose vial, to the hospital level. The product has been found to contain glass particles.
International Laboratories, LLC is voluntarily recalling Lot# 117099A of Clopidogrel Tablets, USP 75 mg, packaged in bottles of 30 tablets, to the consumer level due to mislabeling. The product is labeled as Clopidogrel tablets USP 75 mg but may contain Clopidogrel 75mg or Simvastatin Tablets USP 10 mg.
Amneal Pharmaceuticals, LLC, Bridgewater, New Jersey is voluntarily recalling three lots of Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL), packaged in 480 mL bottles to the Consumer Level. Nizatidine Oral Solution was distributed by Gemini Laboratories, LLC, a wholly owned subsidiary of Amneal Phar
Following the issuance of a voluntary recall dated November 10, 2017 of one lot of NEXTERONE (amiodarone HCl) 150 mg/100 mL Premixed Injection, Baxter International Inc. announced today it is expanding the recall to include a second lot (NC109123) of NEXTERONE due to the potential presence of particulate matter.
January 10, 2018 Lake Forest, IL PharMEDium Services, LLC (PharMEDium) is voluntarily expanding the recall issued on December 27, 2017 to include the below lots of sterile drug products to the hospital/user level due to a lack of assurance of sterility. Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.
December 27, 2017 Lake Forest, IL PharMEDium Services, LLC (PharMEDium) is voluntarily recalling the below lots of drug products to the hospital/user level due to a lack of assurance of sterility. Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening. To date, PharMEDium has not received any reports of complaints related to the products but is issuing this recall out of an abundance of caution following a commitment made during a recent inspection of the company’s facility.
FOR IMMEDIATE RELEASE – 01-12-2018 – East Windsor, New Jersey, AuroMedics Pharma LLC is voluntarily recalling one lot of Levofloxacin in 5% Dextrose Injection 250mg/50mL in a Single-Use flexible container NDC 55150-243-46, Lot CLF160003, Expiry date May 2018, to the hospital level. The product has been found to contain visible particulate matter tentatively identified as mold. This problem was discovered as a result of a product complaint in which the contents of one flexible bag was found to contain white particulate matter
The FDA is providing recommendations and sharing important information with health care providers, pharmacists, compounders, patients and caregivers about the risks of using medications delivered into the spinal fluid to treat or manage pain that are not approved for use with the implanted pumps.
Primus Pharmaceuticals, Inc. of Scottsdale, Arizona is voluntarily recalling all unexpired lots of Limbrel products to the patient (user/consumer) level at FDA's request. FDA has requested a recall of Limbrel due to rare but serious and reversible side effects associated with Limbrel.
Tigard, OR, Magno-Humphries Laboratories, Inc., is voluntarily recalling one lot of Basic Drugs Brand of Senna Laxative tablets, 8.6mg Sennosides to the consumer level due to a customer complaint that their bottle labeled as Senna Laxative actually contained Basic Drugs Brand of Naproxen Sodium 220mg. Naproxen Sodium 220mg tablet is used as a pain reliever and is a nonsteroidal anti-inflammatory drug (NSAID).
Compton, California, Kareway Products, Inc is voluntarily recalling 60,000 lots of Gericare Eye Wash, Sterile Eye Irrigation Solution, 4 fluid ounces to the hospital, retail or consumer level. The product has been found to have potential microbial contamination which compromises sterility.
Apace Packaging LLC is voluntarily recalling one lot of Acyclovir Tablet, USP, 400mg, 50ct Unit Dose, NDC# 50268-061-15, Lot Number 19900, to the Retail level. These products have been recalled due to a product mix-up. A small number of blister cards containing Acyclovir Tablets, 400mg, UD Blister Cards may potentially also include Torsemide, 20mg, Tablets.
Hospira, Inc., a Pfizer company, is voluntarily recalling 3 lots of Labetalol Hydrochloride Injection, USP, 100 mg/20 mL Vial (NDC 0409-2267-20), and one lot of Labetalol Hydrochloride Injection, USP, Novaplus® (NDC 0409-2267-25) to the hospital/institution level. Hospira, Inc. initiated this recall due to the discovery of cracks on the rim surface of vials for these lots, which is covered by the stopper and crimp seal.
FDA is concerned about the health of consumers who may self-medicate by taking ivermectin products intended for animals, thinking they can be a substitute for ivermectin intended for humans.
Because of the potential risk of transmission of SARS-CoV-2 via FMT, FDA has determined that additional protections are needed for any investigational use of FMT, whether under an Investigational New Drug Application (IND) on file with the FDA or under FDA’s enforcement discretion policy. No clinic
The catheter tip can become detached during a patient procedure which could lead to serious injury or death.
LeMaitre is recalling the Over the Wire Embolectomy Catheter because of the possibility of difficulty in balloon deflation during use.
The FDA announced it is requesting manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately.
The infusion pumps deliver fluids and medications. The affected infusion pumps and infusion pump systems lead to over- and under-infusion in patients.
Medtronic is recalling their Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology because there is a risk the device could fracture during use.
Dr. Reddy’s Laboratories Ltd. (along with its subsidiaries together referred to as “Dr. Reddy’s”) announced today that it is voluntarily recalling four lots (ACB902, ACB903, ACB904, ACB905) of Phytonadione Injectable Emulsion USP, 10 mg/mL, Single-Dose Ampules to the hospital level. The product is b
FDA is informing health care providers and patients of the potential risk of transmission of SARS-CoV-2 virus by the use of fecal microbiota for transplantation (FMT)
Recommendations for health care providers and facilities in treating patients who require ventilation assistance due to COVID-19 complications
FDA recognizes that the need for personal protective equipment (PPE), such as medical gloves, may outpace the supply available to health care organizations during the Coronavirus Disease 2019 (COVID-19) outbreak.
CME America, a wholly owned subsidiary of Becton Dickinson, Recalls BodyGuard Microset Infusion Sets Due to Risk of Under-infusion
Natural Remedy Store is voluntarily recalling all lots of Active Male, 500mg capsules to the consumer level. FDA analysis has found the product to be tainted with undeclared tadalafil
FDA is informing health care providers and patients of the potential risk of serious or life-threatening infections with the use of fecal microbiota for transplantation (FMT)
The FDA recognizes that the need for personal protective equipment (PPE), such as surgical masks, surgical and isolation gowns, and surgical suits, may outpace the supply available to healthcare organization during the Coronavirus Disease 2019 (COVID-19) outbreak.
Advanced Bionics (AB), a global leader in developing advanced cochlear implant systems, announced today that it has begun notifying regulatory authorities that it will voluntarily initiate a field corrective action related to the initial version of HiRes Ultra and Ultra 30 cochlear implant devices
BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today provided an update on a previously announced voluntary recall of the BD Alaris™ System regarding software for the PC Unit and certain modules. BD has notified customers affected by this recall, and the
Recalled due to multiple system errors, software errors, and use-related errors which can lead to delay in infusion, interruption of infusion, slower than expected delivery of medication (under-infusion), and faster than expected delivery of medication (over-infusion).
Hikma Pharmaceuticals PLC (Hikma, Group), today announces that its subsidiary Hikma Pharmaceuticals USA Inc. (formerly known as West-Ward Pharmaceuticals Corp.; “Hikma”) is voluntarily extending its previously-announced recall of certain lots (listed below) of Ketorolac Tromethamine Injection USP 30
FDA is strengthening existing warnings about serious behavior and mood-related changes with montelukast (Singulair and generics), which is a prescription medicine for asthma and allergy.
Learn about the SweynTooth cybersecurity vulnerabilities associated with Bluetooth Low Energy (BLE) and recommendations for patients, health care providers, and manufacturers.
The device shows an image on the display while examining a patient’s upper airway. A reverse image is displayed which could cause potential injury.
American Health Packaging has voluntarily recalled eleven (11) lots of Ranitidine Tablets, USP 150 mg, 100 count Unit Dose Blisters to the consumer level due to the potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
The FDA wants to make consumers and health care providers aware that, to date, the FDA has not authorized for market any products using ozone gas or ultraviolet (UV) light to clean, disinfect, or sanitize continuous positive airway pressure (CPAP) devices and accessories.
FDA reminds health care providers and staff of actions to take to reduce the risk of cardiac surgery infection when using the LivaNova Heater-Cooler System 3T.
The U.S. Food and Drug Administration (FDA) is updating our 2014 safety communication on laparoscopic power morcellators to provide new information on the safe and effective use of laparoscopic power morcellation for gynecologic procedures.
The needle is used to remove air from the lung cavity. If the needle is blocked, emergency treatment is delayed which can lead to heart or lung failure.
Taro Pharmaceuticals U.S.A., Inc. (“Taro” or the “Company”) is voluntarily recalling two (2) lots of Phenytoin Oral Suspension USP, 125 mg/5 mL both in 237 mL bottles, to the consumer level. Phenytoin Oral Suspension USP, 125 mg/5 mL is indicated for the treatment of tonic-clonic (grand mal) and psy
Taro Pharmaceuticals U.S.A., Inc. (“Taro” or the “Company”) is voluntarily recalling two (2) lots of Phenytoin Oral Suspension USP, 125 mg/5 mL both in 237 mL bottles, to the consumer level. Phenytoin Oral Suspension USP, 125 mg/5 mL is indicated for the treatment of tonic-clonic (grand mal) and psy
Abbott has voluntarily recalled specific lots of two catheters used in coronary angioplasty procedures: the NC Trek RX Coronary Dilatation Catheter and the NC Traveler Coronary Dilatation Catheter, balloon diameters 4.0mm, 4.5mm and 5.0mm. This recall does not affect patients who have successfully u
The ventilators are used on patients that need breathing support. The sound alarm on the ventilator may fail to alert, presenting a risk of injury or death.
The system provides heated and humidified breathing gases to patients. The system may malfunction causing water to enter the airway causing serious injury.
Coronary dilation catheters are used to open clogged blood vessels to improve blood flow to the heart, Abbot is recalling these devices due to failure of balloon to deflate in certain models, use may cause serious adverse health consequences, such as reduced blow flow to the heart and air embolism.
FDA has requested that the manufacturer voluntarily withdraw the weight-loss drug from the U.S. market because a safety clinical trial shows an increased occurrence of cancer. The drug manufacturer, Eisai Inc,. has submitted a request to voluntarily withdraw the drug.
Missing or broken retainer ring could cause under or over delivery of insulin. This may cause patient injury or death.
A loose cable connection could cause the loss of mechanical ventilation which could lead to serious injury or death.
A manufacturing problem could cause the displayed oxygen values to be incorrect which could lead to serious injury or death.
Efficient Laboratories, Inc. is voluntarily recalling one lot each of Rompe Pecho EX, Rompe Pecho CF, and Rompe Pecho MAXliquid. Specifically, we are recalling the following lots: Rompe Pecho EX lot 19F332, exp June 2022, Rompe Pecho CF lot 19H359, exp August 2022 and Rompe Pecho MAX lot 19B42, ex
Regarding cybersecurity vulnerabilities identified in a wireless telemetry technology used for communication between Medtronic’s implantable cardiac devices, clinic programmers, and home monitors.
FDA is strengthening an existing warning that constipation caused by the schizophrenia medicine clozapine (Clozaril, Fazaclo ODT, Versacloz, generics) can, uncommonly, progress to serious bowel complications. This can lead to hospitalization or even death if constipation is not diagnosed/treated.
The Babi.Plus Pressure Relief Manifold is used as part of a breathing circuit to assist infant patients to breathe. This device is being recalled due to a dislodged valve resulting in loss of pressure in the system. Teleflex issued a Medical Device Recall Notice to affected customers.
King Systems initiated a voluntary recall of One-Hundred Seventy-One (171) units of its King Vision Video Laryngoscope Adapter Size 1/2. The affected products have been found to exhibit a reversed image, which could potentially result in difficulty navigating during intubation and/or delay in intub
The FDA posts Medical Device Safety Communications to describe the FDA's current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient management.
FDA is informing health care providers and facility staff about cybersecurity vulnerabilities that may introduce risks to patients while being monitored using certain GE Healthcare Clinical Information Central Stations and Telemetry Servers.
The medical device manufacturer Cardinal Health alerted its customers to potential quality issues affecting some of its Level 3 surgical gowns and accompanying PreSource procedural packs.
FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutical is voluntarily recalling all unused sterile drug products within expiry, to the user level, due to a lack of assurance of sterility. The recalled sterile products have been found to be inconsistent with federal guidelines.
FDA is sharing recommendations and updates to help improve duodenoscope reprocessing.
FDA is alerting the public that results from a clinical trial assessing safety show a possible increased risk of cancer with the weight management medicine Belviq, Belviq XR (lorcaserin).
Taro Pharmaceuticals U.S.A., Inc. (“Taro” or the “Company”) is voluntarily recalling one (1) lot of Lamotrigine 100 mg Tablets, Lot # 331771 (expiration date June 2021) in 100 count bottles, NDC 51672-4131-1 to the consumer level.
Stryker announced today that the company is launching a voluntary field action on specific units of the LIFEPAK 15 monitor/defibrillators.
Mavidon is voluntarily recalling all lots of products manufactured at our facility including LemonPrep®, PediaPrep® and Wave Prep 4-ounce tubes and single use cups, Cardio Prep and Collodions, Collodion removers due to contamination with Burkholderia cepacia.
Denton Pharma, Inc. dba Northwind Pharmaceuticals, an affiliate of Northwind Pharmaceuticals, LLC (“Northwind”) today announced the voluntary recall of all unexpired lots of Ranitidine Tablets, 150 mg and 300mg, to the consumer level. The recall is in response to the manufacturer’s recall of all un
Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall, to the consumer level, of three lots of Nizatidine Capsules, USP (including the 150mg and 300mg strengths). While Mylan has not received any reports of adverse eve
Appco Pharma LLC (Appco) is voluntarily recalling all quantities and lots, within expiry, of Ranitidine Hydrochloride Capsules to the Consumer level. Ranitidine Hydrochloride Capsules are being recalled because of the presence or potential presence of N-nitrosodimethylamine (NDMA)
Aurobindo Pharma USA, Inc. is voluntarily recalling lot number 03119002A3 of Mirtazapine Tablets to the consumer level. The product is being recalled due to a label error on declared strength; bottles labeled as Mirtazapine 7.5 mg may contain 15 mg tablets.
Mavidon is voluntarily recalling all lots of products manufactured at our facility including LemonPrep®, PediaPrep® and Wave Prep 4-ounce tubes and single use cups, Cardio Prep and Collodions, Collodion removers due to contamination with Burkholderia cepacia.
LivaNova is recalling the VNS Therapy SenTiva Generator System due to an unintended reset error that causes the system to stop delivering VNS therapy.
FDA is warning that serious breathing difficulties may occur in patients using gabapentin or pregabalin who have respiratory risk factors.
The software updates could cause alarms to stop working and cause the battery to drain without warning and potentially interrupt therapy, which could lead to serious injury or death.
Lannett Company, Inc. today announced that it is voluntarily recalling two (2) lots of Levetiracetam Oral Solution, 100mg/mL to the consumer level due to contamination with Bacillus subtilis. The Bacillus subtilis was identified during an evaluation of a raw material used to manufacture the product
The bedside panels and portholes can appear closed without being latched, no longer protect the infant from falling.
Motto International Corp. is voluntarily recalling all lots of Bull Platinum 30000, Stallion Platinum 30000, Rhino 7 Platinum 30000, and Panther Platinum 30000, to the consumer level.
Glenmark Pharmaceutical Inc., USA (“Glenmark”) today announced the voluntary recall of all unexpired lots of Ranitidine Tablets, 150 mg and 300 mg, to the consumer level.
FDA classifies Class I recall for Cook Medical CrossCath® Support Catheters due to radiopaque marker bands being too loose or too tight on certain catheters.
Medtronic received reports of early permanent motor stall due to the presence of foreign particles. Permanent motor stall could lead to serious injury or death.
FDA is informing the public, especially patients, health care practitioners, and clinics, of multiple recent reports of serious adverse events experienced by patients in Nebraska who were treated with unapproved products marketed as containing exosomes.
FDA is informing the public, especially patients, health care practitioners, and clinics, of multiple recent reports of serious adverse events experienced by patients in Nebraska who were treated with unapproved products marketed as containing exosomes.
The FDA is providing the most recent, interim post-approval study results for Abiomed's Impella RP System.
B. Braun Medical Inc. [B. Braun] initiated a voluntary recall of twenty-two (22) lots of Blood Administration Sets. B. Braun identified through complaints and internal discrepancies the potential for leakage at the joint between the blood filters and tubing of these blood administration sets.
The U.S. Food and Drug Administration (FDA) is providing an update on our evaluation of device failures associated with Getinge's Maquet/Datascope intra-aortic balloon pump (IABP) devices: Cardiosave (Hybrid and Rescue), CS300 and CS100/CS100i.
Precision Dose Inc. is voluntarily recalling 5 lots of Ranitidine Oral Solution, USP 150 mg/10 mL to the consumer level. Ranitidine Oral Solution, USP 150 mg/10 mL, is being recalled because of potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
The FDA is evaluating recent reports of Getinge's Maquet/Datascope intra-aortic balloon pump (IABP) devices shutting down while running on battery power.
The remote controllers of some Medtronic MiniMed insulin pumps are vulnerable to cybersecurity risks. Unauthorized persons could record and replay the wireless communication from the remote to the MiniMed insulin pump leading to the administration of one ore more unintended boluses of insulin.
The detector on the Forte Gamma Camera System has the potential to drop without warning which could result in a serious injury or death.
Zimmer Biomet recalled the ROSA Brain Device due to a software issue which can drive the robotic arm to an incorrect position resulting in risks for the patient.
Golden State Medical Supply, Incorporated (GSMS, Inc) based upon a manufacturer’s recall by Novitium Pharma LLC (Novitium), is voluntarily instituting a recall of all quantities and lots, within expiry, of Ranitidine HCl 150mg and 300mg Capsules to the consumer level because of potential presence of
Nature’s Rx is voluntarily recalling lot: 01251ZX1, Expiry Date: 11/2022 of Silver Bullet (10 Male Enhancement Capsules). This recall has been initiated after an FDA laboratory analysis found the product to contain undeclared sildenafil, the active ingredient in Viagra, which is a PDE-5 inhibitor.
Amneal Pharmaceuticals, LLC. Bridgewater, New Jersey is voluntarily recalling Ranitidine Tablets, 150 mg and 300 mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL to the consumer level. A listing of the recalled lots is identified below.
Ranitidine Tablets, USP, 150 mg and 300 mg
American Health Packaging is voluntarily recalling eight lots of Ranitidine Syrup (Ranitidine Oral Solution USP) 150 mg/10 mL Liquid Unit Dose Cups to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the f
Med Man Distribution is voluntarily recalling all lots of Up2 Dietary supplement There is no other all-natural libido for men and women to the consumer level.
Abbott is recalling their CentriMag System due to a calibration system error resulting from electromagnetic interference (EMI) that may cause low or no flow from the device, the console screen to blank, and various inaccurate alarms.
Aurobindo Pharma USA, Inc. is conducting a voluntary recall of 1 lot of Ranitidine Tablets 150mg to the retail level and 37 lots of Ranitidine Capsules 150mg, Ranitidine Capsules 300mg and Ranitidine Syrup 15mg/mL to the consumer level due to the detection of NDMA (Nitrosodimethylamine) Impurity in
The U.S. Food and Drug Administration (FDA) is updating our 2017 safety communication.
The FDA is alerting the public, health care providers, lab personnel, and lab test developers that biotin can significantly interfere with certain lab tests and cause incorrect test results which may go undetected.
Voluntarily Recalling all unexpired lots of LETS GEL KIT Convenience Packs to the hospital, pharmacy and distributor level. The product has been found to potentially contain microbial contamination in the non-sterile Suturagel Methylcellulose base component of the LETS GEL KIT Convenience Packs.
ICU Medical, Inc. (Nasdaq: ICUI) is voluntarily recalling one single lot of Lactated Ringer's Injection, USP, and one single lot of 0.9% Sodium Chloride Injection, USP. The products are being recalled to the hospital level due to the presence of particulate matter.
Some ECHELON FLEX ENDOPATH staplers may contain an out of specification component, which may cause malformed staples, which may cause patient injury or death.
The FDA is evaluating new information about the risk of blood continuing to leak into the aneurysm (Type III endoleak) with Endologix AFX.
Mylan Pharmaceuticals Inc. is conducting a voluntary nationwide recall of one lot (see table below) of Alprazolam Tablets, USP C-IV 0.5 mg, to the consumer/user level. This lot is being recalled due to the potential presence of foreign substance
Voluntarily recalling all quantities and lots, within expiry, of Ranitidine Hydrochloride Capsules in the US to the consumer level. Ranitidine Hydrochloride Capsules are being recalled because of potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
Lannett Company, Inc. today announced that it is voluntarily recalling all lots within expiry of Ranitidine Syrup
Nationwide recall on October 1, 2019, (at the retail level for over-the-counter products and at the consumer level for prescription products) of all of its ranitidine medications sold in US due to confirmed contamination with N-Nitrosodimethylamine (NDMA) above levels established by the FDA
As a precautionary measure, Sanofi on Friday, October 18, intiated a voluntary recall of all Zantac OTC (over-the-counter) in the United States. This includes Zantac 150®, Zantac 150® Cool Mint, and Zantac 75®.
As a precautionary measure, Perrigo Company plc announced today that it has initiated a voluntary, worldwide product recall to the retail customer level of ranitidine (all pack sizes). The recall is being taken due to possible presence of a nitrosamine impurity called N-nitrosodimethylamine (NDMA).
GL Holdings is voluntarily recalling six lots of Green Lumber 2-, 4-, and 10-capsule packages purchased on or before August 10, 2019 to the consumer level. FDA analysis has found one lot of Green Lumber distributed between June and August 2019 to be tainted with tadalafil.
2019 Biologics Recalls
| Date Notification | Brand Name | Product DescriptionImportant Drug Information - Humate-P [Antihemophilic Factor/von Willebrand Factor Complex (Human)]10/16/2019 Medical RecallCSL Behring LLC is alerting customers to a misalignment in the printing of the data on the folding box of Humate-P that might lead to confusion of the user. Viatrexx Bio Incorporated Issues Voluntary Nationwide Recall of Sterile Injectables due to a Lack of Sterility Assurance10/15/2019 Medical RecallViatrexx Bio Incorporated, Newark, Delaware is voluntarily recalling 10 mL sterile injectable vials of products, listed in the table below with lot numbers, to the consumer level. The products were sold exclusively to practitioners for office use. The products were manufactured in a manner that cann Innoveix Pharmaceuticals, Inc. Issues Voluntary Recall of all Sterile Compounded Drug Products Due to a Lack of Sterility Assurance10/10/2019 Medical RecallInnoveix Pharmaceuticals, Inc. is voluntarily recalling all sterile compounded drug products, within expiry, to the consumer level. The products are being recalled due to a lack of assurance of sterility. These concerns arose following a routine inspection of the pharmacy by FDA. 2019 Medical Device Recalls10/08/2019 Medical RecallThe list below contains recalls that were issued in 2019. Medtronic Recalls 6 French Sherpa NX Active Guide Catheters Due to Separation and Fragmentation Issue10/08/2019 Medical RecallMedtronic is recalling the 6 French Sherpa NX Active Guide Catheter due to a risk of the outer material separating from the device resulting in detached fragments that could result in the underlying stainless-steel braid wires being exposed. ICU Medical Issues a Voluntary Nationwide Recall of Certain Lots of Plum and Sapphire Microbore Infusion Sets with Inline Filters10/08/2019 Medical RecallICU Medical, Inc. announced a voluntary recall on 29 July 2019 of certain lots of Plum and Sapphire Microbore Infusion Sets with inline filters due to the potential for small amounts of fluid leaking out of the air vents on the inline filters. To date, ICU Medical is not aware of adverse events rela Lung Injury Update: FDA Warns Public to Stop Using Tetrahydrocannabinol (THC)-Containing Vaping Products and Any Vaping Products Obtained Off the Street10/04/2019 Medical RecallFDA is strengthening its warning to consumers to stop using vaping products containing THC amid more than 1,000 reports of lung injuries—including some resulting in deaths—following the use of vaping products. 2019 Safety Communications10/01/2019 Medical RecallThe FDA posts Medical Device Safety Communications to describe the FDA's current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient management. URGENT/11 Cybersecurity Vulnerabilities in a Widely-Used Third-Party Software Component May Introduce Risks During Use of Certain Medical Devices: FDA Safety Communication10/01/2019 Medical RecallURGENT/11 Cybersecurity Vulnerabilities in a Widely-Used Third-Party Software Component May Introduce Risks During Use of Certain Medical Devices: FDA Safety Communication Teleflex Medical Recalls the Hudson RCI Sheridan and Sheridan Endotracheal Tubes Due to Risk of the Sheridan Connector Disconnecting from the Breathing Circuit09/17/2019 Medical RecallFDA has classified the voluntary action as a Class I recall for the Teleflex Medical Recalls the Hudson RCI Sheridan and Sheridan Endotracheal Tubes Due to Risk of the Sheridan Connector Disconnecting from the Breathing Circuit Ibrance (palbociclib), Kisqali (ribociclib), and Verzenio (abemaciclib): Drug Safety Communication - Due to Rare but Severe Lung Inflammation09/13/2019 Medical RecallFDA is warning that Ibrance (palbociclib), Kisqali (ribociclib), and Verzenio (abemaciclib) used to treat some patients with advanced breast cancers may cause rare but severe inflammation of the lungs. Zantac (ranitidine): Safety Information - NDMA Found in Samples of Some Ranitidine Medicines09/13/2019 Medical RecallFDA has learned that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain NDMA. Ibrance (palbociclib), Kisqali (ribociclib), and Verzenio (abemaciclib): Drug Safety Communication - Due to Rare but Severe Lung Inflammation09/13/2019 Medical RecallFDA is warning that Ibrance (palbociclib), Kisqali (ribociclib), and Verzenio (abemaciclib) used to treat some patients with advanced breast cancers may cause rare but severe inflammation of the lungs. Zantac (ranitidine): Safety Information - NDMA Found in Samples of Some Ranitidine Medicines09/12/2019 Medical RecallFDA has learned that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain NDMA. Tetrahydrocannabinol (THC)-containing Vaping Products: Vaping Illnesses09/09/2019 Medical RecallConsumers are likely aware of the recent reports of respiratory illnesses – including some resulting in deaths – following the use of vaping products.The FDA is working closely with the CDC, as well as state and local public health partners to investigate them as quickly as possible. test article-5/9-FT-Medwatch RSS Feed09/05/2019 Medical Recalltest article-5/9-FT-Medwatch RSS Feed E-Cigarette Products: Safety Communication - Due to the Incidents of Severe Respiratory Disease Associated with Use of an E-Cigarette Product08/30/2019 Medical RecallBoth the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention are working tirelessly to investigate the distressing incidents of severe respiratory disease associated with use of e-cigarette products. Hepatitis C Medicines (Mavyret, Zepatier, and Vosevi): Drug Safety Communication - Due to Rare Occurrence of Serious Liver Injury in Some patients with Advanced Liver Disease08/29/2019 Medical RecallFDA has received reports that the use of Mavyret, Zepatier, or Vosevi to treat chronic Hepatitis C in patients with moderate to severe liver impairment has resulted in rare cases of worsening liver function or liver failure. Xeljanz, Xeljanz XR (tofacitinib): Drug Safety Communication - Due to an Increased Risk of Blood Clots and Death with Higher Dose07/26/2019 Medical RecallDrug Safety Communication - Due to an Increased Risk of Blood Clots and Death with Higher Dose Fecal Microbiota for Transplantation: Safety Communication- Risk of Serious Adverse Reactions Due to Transmission of Multi-Drug Resistant Organisms06/19/2019 Medical RecallFDA MedWatch Alert regarding Fecal Microbiota for Transplantation: Safety Communication- Risk of Serious Adverse Reactions Due to Transmission of Multi-Drug Resistant Organisms E-cigarette: Safety Communication - Related to Seizures Reported Following E-cigarette Use, Particularly in Youth and Young Adults05/16/2019 Medical RecallSafety Communication - Related to Seizures Reported Following E-cigarette Use, Particularly in Youth and Young Adults Certain Prescription Insomnia Medicines: New Boxed Warning - Due to Risk of Serious Injuries Caused by Sleepwalking, Sleep Driving and Engaging in Other Activities While Not Fully Awake04/30/2019 Medical RecallMedWatch Alert on certain prescription insomnia medicines. E-cigarette: Safety Communication - Related to Seizures Reported Following E-cigarette Use, Particularly in Youth and Young Adults04/03/2019 Medical RecallThe FDA has become aware that some people who use e-cigarettes have experienced seizures, with most reports involving youth or young adult users. Xeljanz, Xeljanz XR (tofacitinib): Safety Communication - Safety Trial Finds Increased Risk of Blood Clots in the Lungs and Death with Higher Dose in Rheumatoid Arthritis Patients02/25/2019 Medical RecallFDA is alerting the public that a safety clinical trial found an increased risk of blood clots in the lungs and death when a 10 mg twice daily dose of tofacitinib (Xeljanz, Xeljanz XR) was used in patients with rheumatoid arthritis (RA). FDA has not approved this 10 mg twice daily dose for RA; this dose is only approved in the dosing regimen for patients with ulcerative colitis Fluoroquinolone Antibiotics: Safety Communication - Increased Risk of Ruptures or Tears in the Aorta Blood Vessel in Certain Patients12/20/2018 Medical RecallFDA review found that fluoroquinolone antibiotics can increase the occurrence of rare but serious events of ruptures or tears in the main artery of the body, called the aorta. These tears, called aortic dissections, or ruptures of an aortic aneurysm can lead to dangerous bleeding or even death. They can occur with fluoroquinolones for systemic use given by mouth or through an injection. Gilenya (fingolimod): Drug Safety Communication - Severe Worsening of Multiple Sclerosis After Stopping the Medicine11/20/2018 Medical RecallFDA is warning that when the multiple sclerosis (MS) medicine Gilenya (fingolimod) is stopped, the disease can become much worse than before the medicine was started or while it was being taken. This MS worsening is rare but can result in permanent disability. Implanted Pumps: Safety Communication - Use Caution When Selecting Pain Medicine for Intrathecal Administration11/14/2018 Medical RecallThe FDA is aware that patients undergoing treatment or management of pain are commonly given pain medicines in the spinal fluid (intrathecal administration) that are not FDA approved for use with the implanted pump. SGLT2(sodium-glucose cotransporter-2) Inhibitors for Diabetes: Drug Safety Communication - Regarding Rare Occurrences of a Serious Infection of the Genital Area08/29/2018 Medical RecallRequiring a new warning about this risk to be added to the prescribing information of all SGLT2 inhibitors and to the patient Medication Guide. Temporary Total Artificial Heart Companion 2 Driver System by SynCardia Systems: Letter to Health Care Providers - Risk of Mortality and Stroke08/17/2018 Medical RecallFDA has reviewed the final results from the post-approval study conducted by SynCardia Systems, LLC. for their Temporary Total Artificial Heart (TAH-t) Companion 2 Driver System (C2 Driver System). These final results indicate a higher mortality rate and higher stroke rate for patients initially supported with the C2 Driver System compared to patients initially supported with the previous generation driver, the Circulatory Support System (CSS) Console. Risks Associated with Use of Rupture of Membranes Tests - Letter to Health Care Providers08/08/2018 Medical RecallThe FDA is reminding health care providers that tests to detect rupture of the amniotic membranes should not be used without other clinical assessments to make critical patient management decisions. Zithromax, Zmax (azithromycin): FDA Warning - Increased Risk of Cancer Relapse With Long-Term Use After Donor Stem Cell Transplant08/03/2018 Medical RecallThe antibiotic Zithromax, Zmax (azithromycin) should not be given long-term to prevent a certain inflammatory lung condition in patients with cancers of the blood or lymph nodes who undergo a donor stem cell transplant. Results of a clinical trial found an increased rate of relapse in cancers affecting the blood and lymph nodes, including death, in these patients. Iodine-containing Contrast Agents for Medical Imaging: Drug Safety Communication - Rare Cases of Underactive Thyroid in Infants11/17/2015 Medical RecallLabels of all iodinated contrast media (ICM) products will include information about these cases. No changes to current prescribing, administration, or monitoring practices are recommended.
G5 Ventilator by Hamilton: Class I Recall - Ventilation and Alarm Failure11/14/2015 Medical RecallIf failure occurs, and the operator does not intervene, the patient may not receive enough oxygen and could suffer serious adverse health consequences, including injury or death.
Endoscope Washer/Disinfectors by Custom Ultrasonics: Safety Communication - FDA Recommends Health Care Facilities Transition to Alternate Reprocessing Methods11/13/2015 Medical RecallIdentified facility violations could result in an increased risk of infection transmission.
Plavix (clopidogrel): Drug Safety Communication - Long-term Treatment Does Not Change Risk of Death11/06/2015 Medical RecallFDA review determines that long-term use of clopidogrel does not increase/decrease overall risk of death in patients with, or at risk for, heart disease, and does not suggest that clopidogrel increases risk of cancer/death from cancer.
Myocardial Protection System (MPS) Delivery Sets by Quest Medical: Recall - Intermittent Seal Failure During Use10/29/2015 Medical RecallSeal failure could result in patient blood loss. Auvi-Q (epinephrine injection, USP): Recall - Potential Inaccurate Dosage Delivery10/29/2015 Medical RecallIf a patient experiencing a serious allergic reaction (i.e., anaphylaxis) does not receive the intended dose, there could be significant health consequences, including death. Entacapone: Drug Safety Communication - FDA Review Found No Increased Cardiovascular Risks10/26/2015 Medical RecallDrug labels for Comtan and Stalevo will remain unchanged.
Hepatitis C Treatments Viekira Pak and Technivie: Drug Safety Communication - Risk of Serious Liver Injury10/22/2015 Medical RecallCases of hepatic decompensation and liver failure in patients with underlying liver cirrhosis who were taking these medicines. Kayexalate (sodium polystyrene sulfonate): Drug Safety Communication - FDA Requires Drug Interaction Studies10/22/2015 Medical RecallPrescribers and patients should consider separating Kayexalate dosing from other medications taken by mouth by at least 6 hours.
Downing Labs, LLC Sterile Compounded Products: Recall - Lack of Sterility Assurance10/21/2015 Medical RecallIf there is a contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening.
Heater-Cooler Devices: FDA Safety Communication - Use of Devices Associated With Nontuberculous Mycobacteria Infections10/15/2015 Medical RecallPotential for contaminated water to transmit bacteria through the air (aerosolize) through the device’s exhaust vent into the environment and to the patient.
Acetaminophen Tablets by Medline Industries: Recall - Mislabeling with Incorrect Strength10/15/2015 Medical RecallIf the product is taken at the maximum labeled dose, or with other medications containing acetaminophen, it may lead to liver toxicity or liver failure.
Bioprosthetic Aortic Valves: FDA Notification - Reduced Leaflet Motion10/05/2015 Medical RecallFDA is working to design clinical studies to fully evaluate reduced valve leaflet motion. At this time, FDA believes that bioprosthetic aortic valves remain reasonably safe and effective when used according to their approved indications.
Drug Products Intended to be Sterile by Chen Shwezin Inc., dba Park Compounding Pharmacy: FDA Statement - Lack of Sterility Assurance10/03/2015 Medical RecallAdministration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.
PROFEMUR Neck Varus/Valgus CoCr 8 Degree, Part number PHAC 1254 by MicroPort Orthopedics: Class I Recall - Unexpected Rate of Fractures After Surgery10/02/2015 Medical RecallAcute fracture and emergency revision surgery is a serious adverse health consequence and could lead to neurovascular damage, hematoma, hemorrhage, or death.
Cranial Perforators With an Automatic Clutch Mechanism: Safety Communication - Failure to Disengage09/28/2015 Medical RecallClutch mechanism may fail to disengage if proper use, patient considerations, and device selection are not followed in accordance with the manufacturer’s instructions for use.
Sterile Compounded Products by US Compounding, Inc: Recall - Lack of Sterility Assurance09/24/2015 Medical RecallIf the sterility of a compounded preparation intended to be sterile is compromised, patients may be at risk.
Avycaz (ceftazidime and avibactam): Drug Safety Communication - Dose Confusion and Medication Errors09/22/2015 Medical RecallFDA revised the labels to indicate that each vial contains Avycaz 2.5 gram, equivalent to ceftazidime 2 gram and avibactam 0.5 gram.
Tramadol: Drug Safety Communication - FDA Evaluating Risks of Using in Children Aged 17 and Younger09/21/2015 Medical RecallUltra-rapid metabolizers are more likely to have higher-than-normal amounts of the active form of the opioid in their blood after taking tramadol, which can result in breathing difficulty that may lead to death.
Freedom Driver System by SynCardia: Class I Recall - Part May Fail Causing Device to Stop Working09/18/2015 Medical RecallIf the device stops pumping, the patient will lose consciousness almost immediately, which can lead to serious injury or death.
Ayurvedic Dietary Supplements by Shree Baidyanath: Consumer Advice Notice - Products Contain High Levels of Lead and/or Mercury09/17/2015 Medical RecallTesting has found that these products contain high levels of lead and/or mercury, which can cause serious health problems.
Reprocessed Flexible Bronchoscopes: FDA Safety Communication - Risk of Infection09/17/2015 Medical RecallIf scope reprocessing procedure is not followed meticulously, the flexible bronchoscope can remain contaminated, potentially resulting in infection transmission from one patient to the next.
HeartMate II Left Ventricular Assist System (LVAS) by Thoratec Corporation: Urgent Medical Device Correction - Monitor the Backup Battery Expiration Date09/16/2015 Medical RecallCertain preventable advisory alarms may result in patients deciding to attempt a System Controller exchange.
Clozapine: Drug Safety Communication - FDA Modifies Monitoring for Neutropenia; Approves New Shared REMS Program09/15/2015 Medical RecallEnhanced labeling explaining how to monitor patients for neutropenia/manage clozapine treatment. Approval of new, shared REMS.
Miracle Diet 30 and Miracle Rock 48 Capsules by The One Minute Miracle Inc.: Recall - Due to Presence of Undeclared Drug Products09/12/2015 Medical RecallFDA analysis revealing that these dietary supplements contain undeclared drug products making them unapproved drugs.
Invokana and Invokamet (canagliflozin): Drug Safety Communication - New Information on Bone Fracture Risk and Decreased Bone Mineral Density09/10/2015 Medical RecallFDA added a new Warning and Precaution and revised the Adverse Reactions section of the Invokana and Invokamet drug labels.
Medistat RX Sterile Drug Products: Recall - Possible Contamination09/10/2015 Medical RecallAdministration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.
Compounded or Repackaged Drugs Stored in Becton-Dickinson Syringes: FDA Expands Warning09/08/2015 Medical RecallAn interaction with the rubber stopper in certain lots of these syringes can cause some drugs stored in these syringes to lose potency if filled and not used immediately.
Puritan Bennett 980 Ventilators by Covidien: Class I Recall - Amount of Air Delivered May Be Lower Than Programmed09/02/2015 Medical RecallA patient not receiving enough oxygen can result in possible injury or death.
Evita V500 and Babylog VN500 Ventilators by Dräger Medical: Class I Recall - Faulty Batteries09/02/2015 Medical RecallIf the ventilator shuts down, a patient may not receive necessary oxygen. This could cause patient injury or death.
DPP-4 Inhibitors for Type 2 Diabetes: Drug Safety Communication - May Cause Severe Joint Pain08/28/2015 Medical RecallNew information added to the WARNINGS AND PRECAUTIONS section of the drug labeling.
OmniPod (Pod) Insulin Management System by Insulet Corporation: Recall - Possibility of a Higher Rate of Failure08/28/2015 Medical RecallUse may result in interruption of insulin delivery that can cause hyperglycemia, which, if left untreated, can result in diabetic ketoacidosis.
Alaris Medley Large Volume Pump (LVP) Frame Membrane by Elite Biomedical Solutions: Class I Recall - Frame Membrane May Allow Over or Under Delivery of Fluid by an Infusion Pump08/27/2015 Medical RecallOver or under infusion of fluids to the patient has the potential to cause patient injury or death. Alaris Syringe Pump by CareFusion: Class I Recall - Alarm Error May Cause Interruption of Therapy08/27/2015 Medical RecallFailure of syringe module may result in a delay or interruption of therapy and can lead to serious patient injury or death.
Hudson RCI Sheridan Sher-I-Bronch Endobroncial Tube by Teleflex Medical: Class I Recall - Connector May Crack or Separate08/26/2015 Medical RecallThe connector may break or separate on the tube. If this happens, the device may leak, causing the patient to not receive enough oxygen (hypoxia) or experience respiratory distress.
Refresh Lacri-Lube, Refresh P.M., FML 0.1 Percent and Blephamide 10 Percent/0.2 Percent by Allergan: Recall - Particulate Matter08/25/2015 Medical RecallPotential adverse events may include eye pain, eye sewelling, ocular discomfort or eye irritation.
Picato (ingenol mebutate) Gel: Drug Safety Communication - FDA Warns of Severe Adverse Events, Requires Label Changes08/21/2015 Medical RecallSevere allergic reactions, skin rashes, & cases of shingles (herpes zoster reactivation) reported. Severe eye injuries and skin reactions have occurred when Picato gel is not applied according to recommendations in the label.
OxyTOTE Portable Oxygen Unit by Western/Scott Fetzer Company: Class I Recall - May Ignite and Burst08/18/2015 Medical RecallReports of internal flash fire when the OxyTOTE is mishandled or dropped.
Prolotherapy with Phenol by Hartley Medical: Recall - Non-sterility Concerns08/18/2015 Medical RecallParenteral administration of non-sterile injection products may result in a site-specific or systemic infection, which in turn may cause hospitalization, significant morbidity, or a fatal outcome.
Compounded Drugs Stored in Becton-Dickinson (BD) 3 ml and 5 ml Syringes: FDA Warning - Do Not Use08/18/2015 Medical RecallPreliminary information indicates that drugs stored in these syringes may lose potency over a period of time due to a possible interaction with the rubber stopper in the syringe.
Mammograms at Boston Diagnostic Imaging in Orlanda, Florida: FDA Safety Communication - Quality Problems08/17/2015 Medical RecallPatients should consider having their mammograms re-evaluated at a certified facility.
Beacon Tip Angiographic Catheters by Cook Medical: Class 1 Recall - Catheter Tip May Slip or Separate08/07/2015 Medical RecallIf this occurs, the tip could enter the patient’s bloodstream. This could cause serious injury to the patient and require additional medical intervention to retrieve the tip, or cause death.
Implantable Left Ventricular Assist Devices (LVADs): FDA Safety Communication - Serious Adverse Events08/05/2015 Medical RecallIncreased rate of pump thrombosis, high rate of stroke, bleeding complications. Gilenya (fingolimod): Drug Safety Communication - FDA Warns About Cases of Rare Brain Infection08/04/2015 Medical RecallCases of PML in two patients with no prior exposure to immunosuppressant drugs.
Duodenoscope Reprocessing: FDA Safety Communication - Supplemental Measures to Enhance Reprocessing08/04/2015 Medical RecallHospitals and health care facilities can, in addition to meticulously following manufacturer reprocessing instructions, take additional steps to further reduce the risk of infection.
Hydrochlorothiazide Tablets by Unichem Pharmaceuticals (USA), Inc: Recall - Potential Presence of Foreign Tablets Contamination08/01/2015 Medical RecallMissing a dose of Hydrochlorothiazide could result in uncontrolled blood pressure or swelling caused by excess fluid (edema).
Symbiq Infusion System by Hospira: FDA Safety Communication - Cybersecurity Vulnerabilities07/31/2015 Medical RecallThe device could be accessed remotely through a hospital’s network. This could allow an unauthorized user to control the device and change the dosage the pump delivers, which could lead to over- or under-infusion of critical patient therapies.
0.9 Percent Sodium Chloride Injection, USP (AUTO-C) by Baxter International: Recall - Potential For Leaking Containers, Particulate Matter and Missing Port07/31/2015 Medical RecallLeaking containers, particulate matter and missing port protectors could result in contamination of the solution. If not detected, this could lead to a bloodstream infection or other serious adverse health consequences.
Brintellix (vortioxetine) and Brilinta (ticagrelor): Drug Safety Communication - Name Confusion07/30/2015 Medical RecallFDA warns about prescribing and dispensing errors resulting from brand name confusion with antidepressant Brintellix (vortioxetine) and antiplatelet Brilinta (ticagrelor).
Adrucil (fluorouracil injection, USP) 5 g/100 mL (50 mg/mL) by Teva Parenteral Medicines: Recall - Particulate Matter07/27/2015 Medical RecallAdministration of an intravenous product with particulate matter has the potential to result in inflammation, allergic reactions, or blockage of blood vessels, leading to tissue death, which may be life-threatening if vital organs are affected.
Gadolinium-based Contrast Agents for Magnetic Resonance Imaging (MRI): Drug Safety Communication - FDA Evaluating the Risk of Brain Deposits With Repeated Use07/27/2015 Medical RecallHealth care professionals should consider limiting GBCA use to clinical circumstances in which the additional information provided by the contrast is necessary.
Sterile Human and Veterinary Compounded Drugs by Moses Lake Professional Pharmacy: Recall - Lack of Sterility Assurance07/25/2015 Medical RecallIf there is contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening.
0.9 Percent Sodium Chloride Injection, USP, 50mL and 100mL by Baxter: Recall - Particulate Matter07/20/2015 Medical RecallInjecting a product containing particulate matter, in the absence of in-line filtration, may result in blockage of blood vessels, which can result in stroke, heart attack or damage to other organs.
Proglycem (diazoxide): Drug Safety Communication - Reports of Pulmonary Hypertension in Infants and Newborns07/16/2015 Medical RecallMonitor patients, especially those with risk factors for pulmonary hypertension, for signs of respiratory distress, including tachypnea, flaring nostrils, grunting, and chest wall retractions.
Calcium Chloride Intravenous Infusion 10% w/v 10mL Prefilled Syringe by Mylan: Market Withdrawal - Difficulties in Administration07/14/2015 Medical RecallCalcium Chloride Intravenous Infusion 10% w/v 10mL Prefilled Syringe by Mylan: Market Withdrawal - Difficulties in Administration
Lariat Suture Delivery Device for Left Atrial Appendage (LAA) Closure by SentreHEART: FDA Safety Communication - Reports of Patient Deaths and Other Serious Adverse Events07/13/2015 Medical RecallSafety and effectiveness of the Lariat Suture Delivery Device to close the LAA and prevent stroke in patients with atrial fibrillation has not been established.
Non-aspirin Nonsteroidal Anti-inflammatory Drugs (NSAIDs): Drug Safety Communication - FDA Strengthens Warning of Increased Chance of Heart Attack or Stroke07/09/2015 Medical RecallPatients and health care professionals should remain alert for heart-related side effects the entire time that NSAIDs are being taken.
Lifesaver Single Patient Use Manual Resuscitator by Teleflex Hudson RCI: Class I Recall - Intake Port Blockage07/02/2015 Medical RecallRecalled device may not deliver breathing support to the patient. A delay in treatment may potentially lead to patient injury or death.
Unapproved Prescription Ear Drop (Otic) Products: Not FDA Evaluated for Safety, Effectiveness and Quality07/01/2015 Medical RecallUnapproved products may be contaminated or manufactured incorrectly, which could result in patients receiving the wrong dose, even when administered according to the labeled directions for use.
Codeine Cough-and-Cold Medicines in Children: Drug Safety Communication - FDA Evaluating Potential Risk of Serious Side Effects07/01/2015 Medical RecallFDA investigating the safety of codeine-containing medicines to treat coughs and colds in children under 18 years because of the potential for slowed or difficult breathing.
FLOW-i Anesthesia Systems by Maquet: Class 1 Recall - Dislodged Patient Cassette May07/01/2015 Medical RecallMay cause anesthesia gas to leak and could prevent the ventilator from providing breathing support if not corrected immediately.
Daytrana Patch (methylphenidate transdermal system): Drug Safety Communication - Permanent Skin Color Changes06/24/2015 Medical RecallNew warning added to drug label to describe risk of chemical leukoderma. chemical leukoderma, have been associated with the use of the Daytrana patch.
Covidien Shiley Neonatal and Pediatric Tracheostomy Tubes by Medtronic: Recall - Tubes Formed With Wider-angle Bend Than Standard Models06/24/2015 Medical RecallReports of 12 serious patient injuries, including breathing difficulties that impacted oxygen levels in patients.
HeartWare Ventricular Assist System: Class I Recall – Updated with Multiple Reasons for Recall06/22/2015 Medical RecallFDA will update recall with new information as it becomes available.
M/L Taper with Kinectiv Technology Prosthesis by Zimmer: Class I Recall - Higher than Expected Levels of Manufacturing Residues06/20/2015 Medical RecallCan cause serious adverse health issues including allergic reactions, pain, infections, or death.
HeartWare Ventricular Assist System: Class I Recall - Damaged Alignment Guides or Connection Pins May Cause Pump to Stop06/16/2015 Medical RecallAn interruption in electrical connection would cause the pump to stop, which could cause serious patient injury or death.
Potiga (ezogabine): Drug Safety Communication - FDA Determines 2013 Labeling Adequate to Manage Risks of Retinal Abnormalities, Potential Vision Loss, and Skin Discoloration06/16/2015 Medical RecallHealth care professionals should continue to follow the recommendations provided in the BOXED WARNING, FDA’s most serious type of warning, and the WARNINGS AND PRECAUTIONS and INDICATIONS AND USAGE sections of the labeling.
Vascu-Guard Peripheral Vascular Patch by Baxter: Recall - Difficulty Distinguishing the Smooth from Rough Surface06/03/2015 Medical RecallIncorrect orientation of the patch with the rough side toward the bloodstream may increase the risk of vessel thrombosis and/or embolism. Posted 06/03/2015
Unintentional Injection of Soft Tissue Filler into Blood Vessels in the Face: FDA Safety Communication - Risk of Serious Patient Injury05/28/2015 Medical RecallRisk of embolization, which can cause vision impairment, blindness, stroke and damage and/or death of the skin and underlying facial structures.
Avea Ventilator by CareFusion: Recall - Potential Malfunction of Pressure Transducer05/27/2015 Medical RecallVentilator may activate false Extended High Ppeak or Circuit Occlusion audio and visual alarms, open the safety valve and stop ventilating.
Zerbaxa (ceftolozane and tazobactam): Drug Safety Communication - FDA Cautions about Dose Confusion and Medication Errors05/20/2015 Medical RecallCan lead to to administration of more drug than was prescribed.
SGLT2 inhibitors: Drug Safety Communication - FDA Warns Medicines May Result in a Serious Condition of Too Much Acid in the Blood05/15/2015 Medical RecallHigh levels of blood acids called ketones may require hospitalization. Posted 05/15/2015
LifeCare PCA3 and PCA5 Infusion Pump Systems by Hospira: FDA Safety Communication - Security Vulnerabilities05/13/2015 Medical RecallAn unauthorized user with malicious intent could access the pump remotely and modify the dosage it delivers, which could lead to over- or under-infusion of critical therapies.
Tiger Paw System II by Maquet Medical Systems: Class I Recall - May Cause Tears and Bleeding in Heart Tissue05/07/2015 Medical RecallPossibility of a tear on the left atrial wall during use of the device.
Adrucil (fluorouracil Injection, USP) 5 g/100 mL (50 mg/mL): Recall - Particulate Matter05/05/2015 Medical RecallAdministration of product with particulate matter has potential to result in inflammation, allergic reactions, or blockage of blood vessels, which may be life-threatening if vital organs are affected.
Mammograms at Coastal Diagnostic Center in Pismo Beach, California: FDA Safety Communication - Quality Problems04/30/2015 Medical RecallPatients may need a repeat mammogram or additional medical follow-up.
Injectable Products by Mylan: Recall - Presence of Particulate Matter04/24/2015 Medical RecallAdministration of a sterile injectable that has foreign particulates has the potential of severe health consequences.
Bupivacaine HCl Injection by Hospira: Recall - Iron Oxide Particulate In Glass Vials04/24/2015 Medical RecallInjected particulate may result in local inflammation, low-level allergic or immune responses, granuloma formation or mechanical irritation of tissue.
Ebola Virus One-Step Test Kits by LuSys Laboratories: Class I Recall - Not Cleared for Marketing04/23/2015 Medical RecallThe results obtained from these test kits have not been demonstrated to be accurate and should not be used as diagnostic tests for Ebola infection. Posted 04/23/2015
Mucinex Fast-MAX Products: Recall - Incorrect Labeling04/22/2015 Medical RecallConsumers could take a product with undeclared levels of acetaminophen, dextromethorphan, guaifenesin, phenylephrine and/or diphenhydramine.
Flurbiprofen-Containing Topical Pain Medications: FDA Alert - Illnesses and Deaths in Pets Exposed to Prescription Topical Pain Medication04/17/2015 Medical RecallEvidence of NSAID toxicity in the pets exposed to flurbiprofen and died.
VV13F Reinforced Dual Lumen ECMO Catheters by OriGen Biomedical: Recall - Potential for Separation of Tube from Hub04/16/2015 Medical RecallSeparation could result in required intervention to prevent permanent impairment or damage.
Intravenous (IV) Solutions (Select Lots) by Baxter: Recall - Potential Presence of Particulate Matter04/10/2015 Medical RecallParticles in IV solutions may cause: local vein irritation, inflammatory reaction, aggravation of preexisting infections, allergic reactions, and systemic embolization.
Products from Prescription Center Pharmacy in Fayetteville, N.C.: Recall - Lack of Sterility Assurance04/02/2015 Medical RecallHuman and veterinary drug products made by the Prescription Center have been distributed nationwide and to Canada.
Feraheme (ferumoxytol): Drug Safety Communication – Warnings Strengthened and Prescribing Instructions Changed03/31/2015 Medical RecallRisk of potentially life-threatening allergic reactions.
Duodenoscope Model TJF-Q180V by Olympus: FDA Safety Communication - New Reprocessing Instructions Validated03/26/2015 Medical RecallIf not properly reprocessed patients may be exposed to serious infections.
Mammograms at Richard D. Adelman M.D. in Raleigh, North Carolina: FDA Safety Communication - Quality Problems03/24/2015 Medical RecallThe facility may not perform mammography due to the revocation of its accreditation.
Hepatitis C Treatments Containing Sofosbuvir in Combination With Another Direct Acting Antiviral Drug: Drug Safety Communication - Serious Slowing of Heart Rate When Used With Antiarrhythmic Drug Amiodarone03/24/2015 Medical RecallPostmarketing cases of serious and life-threatening symptomatic bradycardia, as well as one fatal cardiac arrest and cases requiring pacemaker insertion, have been reported.
Zyprexa Relprevv (olanzapine pamoate): Drug Safety Communication - FDA Review of Study Sheds Light on Two Deaths Associated with the Injectable Schizophrenia Drug03/23/2015 Medical RecallFDA is unable to exclude the possibility that the deaths were caused by rapid, but delayed, entry of the drug into the bloodstream following intramuscular injection.
Over-the-Counter Asthma Products Labeled as Homeopathic: FDA Statement - Consumer Warning About Potential Health Risks03/19/2015 Medical RecallIf asthma is not appropriately treated and managed, patients may be at risk for life-threatening asthma attacks.
Lactated Ringer's Irrigation, 3000mL by Hospira: Recall - Mold Contamination03/12/2015 Medical RecallContaminated solution used on a patient may result in bacteremia, sepsis, septic shock and endocarditis, and death may result.
Treanda (bendamustine hydrochloride) Solution by Teva: FDA Statement - Not Compatible with Closed System Transfer Devices, Adapters, and Syringes Containing Polycarbonate or Acrylonitrile-Butadiene-Styrene03/11/2015 Medical RecallCan lead to device failure, possible product contamination, and potential serious adverse health consequences.
Chantix (varenicline): Drug Safety Communication - FDA Updates Label to Include Potential Alcohol Interaction03/09/2015 Medical RecallRare risk of seizures, and studies of side effects on mood, behavior, or thinking. Posted 03/09/2015
Magnesium Sulfate in 5 Percent Dextrose Injection by Hospira: Recall - Incorrect Barcode Labeling03/06/2015 Medical RecallPotential for delay in treatment of magnesium sulfate in 5% dextrose, that can result in life-threatening seizures, stroke, cerebral hemorrhage and maternal death, and attendant risks to the fetus, including fetal demise.
Plum A+ and Plum A+3 Infusion Systems by Hospira: Class I Recall - Alarm Volume Failure03/06/2015 Medical RecallRisk of injury or death resulting from prolonged interruption in therapy.
0.9 Percent Sodium Chloride Injection, USP, 250 mL VisIV Container by Hospira: Recall - Particulate Matter03/06/2015 Medical RecallInjected particulate material may result in localized inflammation, phlebitis, allergic reaction, granuloma formation or microembolic effects, and/or low-level allergic response.
Testosterone Products: Drug Safety Communication - FDA Cautions About Using Testosterone Products for Low Testosterone Due to Aging; Requires Labeling Change to Inform of Possible Increased Risk of Heart Attack And Stroke03/03/2015 Medical RecallFDA requiring manufacturers to change labeling to clarify the approved uses of these medications, and to add information about a possible increased risk of heart attacks and strokes in patients taking testosterone.
HeartWare Ventricular Assist System Controllers by HeartWare International: Recall - Clinical Trial Controllers Susceptible to Electrostatic Discharge02/27/2015 Medical RecallElectrostatic discharge event could result in a pump stop, which could cause serious injury or death. Colistimethate for Injection USP, 150 mg and Rifampin for Injection USP, 600 mg/vial by Heritage Pharmaceuticals: Recall - Lack of Sterility Assurance02/25/2015 Medical RecallAdministration of non-sterile injection products may result in a site-specific or systemic infection, with the potential to cause hospitalization, permanent organ damage, or death.
Magnetic Resonance Imaging (MRI) Systems with Magnet Rundown Unit by GE Healthcare: Class I Recall - Potential Disabling of the Magnet Rundown Unit02/25/2015 Medical RecallRisk of life-threatening injuries or death if a metal object is brought into the magnetic field.
MAQUET Servo Humidifier 163 by Teleflex Medical: Class I Recall - Cracks in Connector Tubes May Lead to Leak Failures02/25/2015 Medical RecallCracks may prevent device from delivering sufficient support to the patient. This may potentially cause serious injury or death.
Atracurium Besylate Injection by Sagent Pharmaceuticals: Recall - Potential Impact on Product Sterility02/24/2015 Medical RecallHas the potential to result in infections, which could be fatal, especially in patients who are immunocompromised.
Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes: FDA Safety Communication - Design May Impede Effective Cleaning02/19/2015 Medical RecallPatients may be exposed to serious infections.
Ketorolac Tromethamine Injection by Hospira: Recall - Particulate in Glass Vials02/11/2015 Medical RecallAdministration of particulates has the potential for localized inflammation, allergic reaction, granuloma formation, microembolic effects, or delay of therapy.
Trellis 6 and Trellis 8 Peripheral Infusion Systems by Covidien: Class I Recall - Balloon Inflation Ports Mislabeled02/11/2015 Medical RecallThe physician using the device may deflate the balloons in the incorrect order. If this happens, there is a potential for blood clots to dislodge and move into the lungs.
0.9 Percent Sodium Chloride Injection, USP, 250 mL by Hospira : Recall - Particulate Matter01/23/2015 Medical RecallInjected particulate material may result in local inflammation, phlebitis, and/or low-level allergic response.
Bone Graft Substitutes Containing Recombinant Proteins or Synthetic Peptides in Patients Under Age 18: FDA Safety Communication - Reports of Serious Injuries01/21/2015 Medical RecallRisk of excess bone growth, fluid accumulation, inhibited bone healing, and swelling.
Simulated IV Solutions from Wallcur: CDER Statement- FDA's Investigation into Patients being Injected01/14/2015 Medical RecallAdverse events include fever, chills, tremors and headache,and there is one death associated with the use of these products.
Prescription and Over-the-Counter (OTC) Pain Medicines: Drug Safety Communication - FDA Review of Possible Risks of Pain Medicine Use During Pregnancy01/09/2015 Medical RecallPregnant women urged to discuss all medicines with their health care professionals before using them.
Virazole (Ribavirin Powder For Solution) by Valeant Pharmaceutical North America, LLC: Recall- Due to Microbial Contamination01/02/2015 Medical RecallInhalation of a non-sterile product with microbial contamination into the airways could increase the risk of respiratory infection.
KimVent Microcuff Subglottic Suctioning Endotracheal Tubes by Halyard Health: Class I Recall - Component May Detach During Use12/31/2014 Medical RecallAn air leak between cuff and tracheal wall may reduce the amount of air that reaches the lungs. Use of this recalled product could cause serious health risks, including delayed patient treatment, breathing difficulties, and death.
Nellcor Puritan Bennett 980 Ventilator System by Covidien: Class I Recall - Component Failure May Cause Burning Odor12/31/2014 Medical RecallProblems in the manufacturing process may lead to unexpected need to stop the ventilator and transfer the patient to another ventilator.
IV Solutions from Wallcur of San Diego: CDER Statement - FDA Warns Health Care Professionals Not to Inject Patients12/31/2014 Medical RecallThere have been reports of serious adverse events associated with the use of certain of these products.
Caramel Apples: Warning - Illnesses, Including Deaths, Linked to Listeria Monocytogenes Contamination12/26/2014 Medical RecallListeriosis can be fatal, especially in certain high-risk groups, including the elderly, and people with weakened immune systems and certain chronic medical conditions (such as cancer).
Mitoxantrone by Hospira: Recall - Confirmed Subpotency and Out-Of-Specification12/24/2014 Medical RecallPotential for decreased potency which can lead to decreased effectiveness, additional dosing, and the potential for cumulative impurity toxicity requiring medical intervention.
B-Lipo Capsules by Bethel Nutritional Consulting, Inc.: Recall - Undeclared Drug Ingredient12/22/2014 Medical RecallSerious adverse events, which may be life-threatening, include damage to the heart valve, or serotonin syndrome particularly if taken with other medications that work similarly.
SLIM-K Capsules by Bethel Nutritional Consulting, Inc.: Recall - Undeclared Drug Ingredients12/22/2014 Medical RecallCan increase blood pressure and/or pulse rate, interact in life threatening ways with other medications, casue serious GI disturbances, irregular heartbeat, and cancer with long-term use.
0.9 Percent Sodium Chloride Injection USP in 100 mL MINI-BAG PLUS Container by Baxter: Recall - Particulate Matter12/16/2014 Medical RecallIntravenous administration of a solution containing particulate matter may lead to local vein irritation, inflammatory reaction, aggravation of preexisting infections, allergic reactions, and systemic embolization.
Ziprasidone (Marketed as Geodon and Generics): Drug Safety Communication - Rare But Potentially Fatal Skin Reactions12/11/2014 Medical RecallSymptoms may include a rash that can spread to all parts of the body, fever, swollen lymph nodes, and inflammation of organs such as the liver, kidney, lungs, heart, or pancreas.
Dietary Supplements Containing Live Bacteria or Yeast in Immunocompromised Persons: Warning - Risk of Invasive Fungal Disease12/09/2014 Medical RecallFDA advises practitioners to approach the application of these interventions with caution.
Heart Sync Inc. Multi-function Defibrillation Electrodes: Device Correction - Connector Incompatibility with Philips FR3 and FRx Defibrillator Units12/03/2014 Medical RecallMay result in a delay in therapy.
Siemens Healthcare Diagnostics, Rapid Gram Negative Combo Panels: Class I Recall - May Produce Incorrect Results12/02/2014 Medical RecallUsing these recalled devices may cause ineffective patient treatment.
CONMED PadPro and R2 Multi-function Defibrillation Electrodes: Device Correction - Connector Compatibility Issue With Philips FR3 and FRx Defibrillator Units11/26/2014 Medical RecallMay result in a delay in therapy.
Slim-Vie: Public Notification - Undeclared Drug Ingredient11/26/2014 Medical RecallSibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
Tecfidera (dimethyl fumarate) by Biogen Idec: Drug Safety Communication - Case of Rare Brain Infection PML Reported11/25/2014 Medical RecallSymptoms of PML may include: progressive weakness on one side of the body or clumsiness of limbs; disturbance of vision; and changes in thinking, memory and orientation. The progression of deficits can lead to severe disability or death.
Black Storm: Public Notification - Undeclared Drug Ingredient11/24/2014 Medical RecallSildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.
Super Extreme Accelerator: Public Notification - Undeclared Drug Ingredient11/24/2014 Medical RecallSibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
Bee Thin: Public Notification - Undeclared Drug Ingredient11/24/2014 Medical RecallSibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
Bee Slim: Public Notification - Undeclared Drug Ingredient11/24/2014 Medical RecallSibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
Gabapentin Capsules, USP 300 mg, by Aurobindo Pharma USA: Recall - Complaints of Empty Capsules11/24/2014 Medical RecallRisk of missed dose(s) resulting in no effect, short term reduction in efficacy, short term withdrawal effect, or status epilepticus (long period seizures) that could be life-threatening.
Highly Concentrated Potassium Chloride Injection, 10 mEq per 100 mL by Baxter: Recall - Mislabeled Overpouch11/21/2014 Medical RecallAdministration of a dose lower than intended, especially in patients prone to severe electrolyte imbalance, may lead to serious, life-threatening adverse health consequences.
Forever Beautiful Bee Pollen by REFA Enterprises: Recall - Undeclared Drug Ingredients11/20/2014 Medical RecallRisk for those with a history of coronary artery disease, congestive heart failure, arrhymias or stroke
Respironics California, Esprit V1000 and V200 Ventilators: Class I Recall - Power Failure May Occur11/19/2014 Medical RecallFailure of power supply may cause ventilator to shut off, resulting in too much carbon dioxide or not enough oxygen in patient’s blood, or death.
ABC Dophilus Powder by Solgar, Inc: Recall - Risk of Infection11/17/2014 Medical RecallThe product was found to contain Rhizopus oryzae, which may cause health problems to consumers, particularly premature infants/infants, children, and those with weakened immune systems.
Long-term Antiplatelet Therapy: Safety Announcement - Preliminary Trial Data Shows Benefits But a Higher Risk of Non-Cardiovascular Death11/16/2014 Medical RecallFDA believes the benefits of clopidogrel (Plavix) and prasugrel (Effient) therapy continue to outweigh their potential risks when used for approved uses.
Gel-E Donut and Squishon 2 Products by Children’s Medical Ventures: Recall - Potential Mold Contamination11/15/2014 Medical RecallThere is the possibility of fungal infection should patients come in contact with the mold.
Mayhem: Public Notification - Undeclared Drug Ingredients11/14/2014 Medical RecallRisk of impaired ability to fight infections, high blood sugar levels, muscle injuries, and psychiatric problems.
Nellcor Puritan Bennett, 980 Ventilator System: Class I Recall - Software Issue May Stop Ventilator11/07/2014 Medical RecallVentilator may stop working after the air and oxygen gas supply lines are disconnected and then reconnected. This can lead to serious health problems or death.
GemStar Power Supply, 3VDC for GemStar Infusion Pumps by Hospira: Class I Recall - Power Supply May Not Deliver Enough Electricity11/05/2014 Medical RecallUse of recalled devices may cause serious health risks, including delay in therapy, delivery of too much fluid, too high or too low blood pressure, slow or fast heart rhythm/beat, shock, trauma, 1st or 2nd degree burns, smoke inhalation, problems breathing, stroke, and death.
V26 Slimming Coffee: Public Notification - Undeclared Drug Ingredient11/05/2014 Medical RecallSibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
10 Percent Neutral Buffered Formalin by Richard-Allan Scientific: Class I Recall - May Contain Incorrect Concentration of Formalin10/31/2014 Medical RecallUse of this defective Formalin may prevent or delay diagnoses and treatment decisions.
Ginseng Kianpi Pil: Public Notification - Undeclared Drug Ingredients10/31/2014 Medical RecallRisk of impaired ability to fight infections, high blood sugar levels, muscle injuries and psychiatric problems. Undeclared drug ingredients may also cause serious side effects when combined with other medications.
Baby Wipes by Nutek Disposables, Inc.: Recall - May Contain Bacteria10/27/2014 Medical RecallThose with weakened immune system or chronic lung disease may be more susceptible to infections with B. cepacia.
Intravia Containers by Baxter: Recall - Particulate Matter10/25/2014 Medical RecallIntravenous administration of a solution containing sterile particulate matter may lead to adverse health consequences. Posted 10/25/2014
Assured Brand Naproxen Sodium Tablets by Contract Packaging Resources, Inc.: Recall - Packaging Mix-Up10/22/2014 Medical RecallRisk of allergic reactions, from mild irritation or hives to serious reactions such as anaphylaxis that may be life-threatening.
Saba Shark Cartilage Complex, 60 Capsule Bottles: Recall - Possible Salmonella Contamination10/20/2014 Medical RecallSalmonella can cause serious and sometimes fatal infections in young children frail or elderly people, and others with weakened immune systems. Posted 10/20/2014
Lidocaine HCI Injection, USP 10 MG Per ML, 30 ML Single-Dose, Preservative-Free, by Hospira: Recall - Particulate Matter10/17/2014 Medical RecallInjected particulate material may result in local inflammation, phlebitis, and/or low-level allergic response to the particulate or microembolic effects.
September 201410/16/2014 Medical RecallSeptember 2014 Drug Safety Labeling Changes includes 55 products with revisions to Prescribing Information.
LifeCare Flexible Intravenous Solutions by Hospira, Inc.: Recall - Potential for Leakage10/15/2014 Medical RecallA puncture in the primary container may be difficult to detect and lead to contamination, compromised sterility, and other adverse events.
Medi-Trace Cadence and Kendall Multi-function Defibrillation Electrodes by Covidien: Field Safety Alert - Electrodes Will Not Connect with Philips FR3 or FRx AED units10/13/2014 Medical RecallThe mismatch of these devices could contribute to a delay in resuscitation and may contribute to subsequent death.
Sit and Slim II: Public Notification - Hidden Drug Ingredients10/10/2014 Medical RecallFDA analysis found these products to contain undeclared Sibutramine, which may increase blood pressure and/or pulse rate, and may also interact in life-threatening ways with other medications.
CareFusion EnVe and ReVel Ventilators: Class 1 Recall - Power Connection Failure10/10/2014 Medical RecallVentilator shut-off from power failures may lead to serious patient injury or death.
ICU Medical ConMed Stat2 Flow Controller: Class 1 Recall - Delivers Higher Flow Rate than Intended10/10/2014 Medical RecallUse of the affected product may cause serious adverse health consequences, including death.
Oregon Compounding Centers, Inc. Unexpired Sterile Products: Recall - Lack of Sterility Assurance10/10/2014 Medical RecallPatients in Oregon and Washington may be at risk of serious infections which may be life threatening.
Vancomycin Hydrochloride for Injection USP, Equivalent to 1 Gram Vancomycin (Sterile Powder) by Hospira, Inc.: Recall - Uncontrolled Storage During Transit10/08/2014 Medical RecallOne lot may have experienced temperature excursions during shipment.
SAM Junctional Tourniquet Accessory (Axilla) Strap - SAM Medical Products: Recall - Potential Clip Failure10/08/2014 Medical RecallProduct failure could cause a potential delay in controlling axilla hemorrhage.
Hudson RCI Pediatric Anesthesia Breathing Circuits by Teleflex Medical: Class I Recall - Circuit Ends May Crack or Break10/07/2014 Medical RecallDefect could cause serious health risks, including delayed patient treatment, breathing difficulties, or death if not replaced immediately.
Ketorolac Tromethamine Injection, USP, 30mg/ml by Sagent Pharmaceuticals: Recall - Incorrect Labeling10/06/2014 Medical RecallThe labeled expiration date is longer than the known stability of the product.
Bo Ying Compound by Eu Yan Sang (Hong Kong) Ltd: FDA/CDER Statement - Risk of Lead Poisoning09/27/2014 Medical RecallExposure to lead can cause serious damage to the central nervous system, the kidneys, and the immune system.
Xolair (omalizumab): Drug Safety Communication - Slightly Elevated Risk of Cardiovascular and Cerebrovascular Serious Adverse Events09/26/2014 Medical RecallFDA approves label changes after review of a five year safety study.
Potassium Chloride Injection (Baxter): Recall - Shipping Carton Mislabeling09/17/2014 Medical RecallPotential risk of medication error or delay in therapy for patients that require high concentration potassium chloride.
Heparin Sodium, 1,000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), In 0.9 percent Sodium Chloride Injection, 500 mL by Hospira: Recall - Particulate Matter09/12/2014 Medical RecallRisk of injected particulate material which may result in local inflammation, phlebitis, and/or low-level allergic response.
Pharmacy Creations Certain Products: Recall – Potential Non-Sterility09/06/2014 Medical RecallCompromised sterility of a product may lead to risk for infection
Martin Avenue Pharmacy, Inc. Compounded Sterile Preparations: Recall - Lack of Assurance of Sterility09/02/2014 Medical RecallCompromised sterility of a compounded preparation may lead to risk for infection.
Dermatend Original and Dermatend Ultra: Recall - Safety Concerns09/02/2014 Medical RecallUsing these Dermatend products instead of seeking medical attention could result in delayed diagnosis of conditions such as cancer.
DePuy Synthes Craniomaxillofacial Distraction System: Class I Recall - May Reverse Directions After Surgery08/28/2014 Medical RecallInfants at highest risk for injury. Sudden obstruction of trachea could lead to respiratory arrest/death. In all patient populations, failure may result in need for surgical intervention to replace failed device.
Sterile Convenience Surgical Packs by Customed, Inc.: Recall - Potential Loss of Sterility08/26/2014 Medical RecallPotential adhesion defect which may lead to infection.
Children’s Medical Ventures Gel-E Donut and Squishon 2: Class 1 Recall - Possibility of Mold08/22/2014 Medical RecallCladosporium and Penicillium Fungi which may cause difficulty in breathing, allergic reactions and serious health consequences, including death.
CloverSnare 4-Loop Vascular Retrieval Snare by Cook Medical: Recall - Risk of Loop to Separate From Shaft08/20/2014 Medical RecallUse of affected product may result in loss of device function, potential for embolization of snare fragments, and the potential need for intervention to retrieve the separated snare.
Diamondback 360 Peripheral Orbital Atherectomy System by Cardiovascular Systems: Class I Recall - Sheath May Fracture During Use08/19/2014 Medical RecallFragments of the sheath could possibly block blood vessels.
Dianeal Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with 2.5 Percent Dextrose 5000mL (Ambu-Flex II): Recall - Presence of Particulate Matter08/15/2014 Medical RecallParticulate matter could potentially serve as a focal point for infection should any pre-existing peritonitis exist, and may lead to a fatal outcome.
IPM Wound Gel by Edwards Pharmaceuticals: Class I Recall - Microbial Contamination08/12/2014 Medical RecallUse of the affected product may cause serious adverse health consequences, including sepsis, limb loss, and death.
Arize: Public Notification - Undeclared Drug Ingredient08/11/2014 Medical RecallUndeclared sulfoaildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.
Herbal Vigor Quick Fix: Public Notification - Undeclared Drug Ingredient08/11/2014 Medical RecallUndeclared tadalafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.
CUBICIN (daptomycin for injection) 500 mg in 10 mL Single Use Vials: Recall - Foreign Particulate Matter08/09/2014 Medical RecallAdministration of particulate matter poses a potential safety risk to patients such as a thromboembolism or a life-threatening pulmonary embolism.
White and Blue Lion Tattoo Kits: Recall - Bacterial Contamination of Needles and Ink Bottles08/08/2014 Medical RecallUse of these products may cause bacterial infection and can lead to sepsis, a potentially life-threatening complication of an infection.
RegenESlim Appetite Control Capsules: Recall - Presence Of DMAA08/08/2014 Medical RecallDMAA can narrow blood vessels and arteries, which can cause a rise in blood pressure or other cardiovascular problems such as shortness of breath, arrhythmias, tightening in the chest, and heart attack.
Cubicin (daptomycin for injection) 500 mg in 10 mL Single Use Vials: Recall - Presence Of Particulate Matter08/08/2014 Medical RecallThe administration of a glass particulate poses a potential safety risk to patients such as a thromboembolism or a life-threatening pulmonary emboli.
Expression Injectable by Enhancement Medical: FDA Safety Communication - Adverse Events Associated with Unapproved Use As a Dermal Filler08/05/2014 Medical RecallEvents have included swelling, tenderness, firmness, lumps, bumps, bruising, pain, redness, discoloration, itching, and the development of hard nodules.
Lidocaine HCI Injection, USP, 2 percent, by Hospira: Recall - Visible Particulates07/30/2014 Medical RecallInjected particulate could result in delay in therapy, local inflammation, mechanical disruption of tissue or immune response to the particulate.
GE Healthcare, LLC, Single-Width Airway Modules (E-MiniC) and Accessories and Extension Modules (N-FC, N-FCREC): Class I Recall - CO2 Detector May Fail Leading to Injury07/25/2014 Medical RecallPhysicians may make decisions based on incorrect values which could lead to permanent, irreversible impairment or life-threatening changes in patients.
Ibuprofen and Oxcarbazepine Tablets by American Health Packaging: Recall - Mislabeled Packaging07/21/2014 Medical RecallFailure to receive the proper dose of oxcarbazepine could increase the chances of patients having a seizure and inadvertent consumption of ibuprofen may cause adverse reactions.
Sterile Drug Products by Downing Labs (aka NuVision Pharmacy): Drug Alert - Lack of Sterility Assurance07/19/2014 Medical RecallAdministration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death
Baxter IV Sodium Chloride and Potassium Chloride Solutions: Recall - Particulate Matter07/18/2014 Medical RecallIf infused, the presence of particulate foreign matter may elicit inflammatory and allergic responses, both chronic and acute, and may be life threatening.
Sterile Drug Products by Unique Pharmaceuticals Ltd.: Alerting Health Care Professionals - Lack of Sterility Assurance07/12/2014 Medical RecallAdministration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.
Hospira Lactated Ringer's And 5% Dextrose Injection, 1000 ML, Flexible Containers: Recall (One Lot) - Mold Contamination07/11/2014 Medical RecallVoluntary Nationwide Recall Of One Lot. Intravenous administration of a non-sterile product can result in infections that may be life-threatening, and may result in prolonged hospitalization or organ failure.
Weight Loss Products: Public Notification - Undeclared Drug Ingredients07/09/2014 Medical RecallMay present significant risk for patients with history of CAD, CHF, arrhythmias, or stroke. May interact, in life-threatening ways, with other medications.
Langston V2 Dual Lumen Catheters (Models 5540 and 5550) by Vascular Solutions: Class I Recall - Inner Catheter May Separate During Use and Cause Injury07/07/2014 Medical RecallThe use of affected product may cause serious adverse health consequences, including death.
Medtronic Duet External Drainage and Monitoring System, Medtronic Neurosurgery: Class 1 Recall - Tubing May Disconnect and Lead to Injury07/02/2014 Medical RecallDevice failure may result in air within skull, infection, and over/under drainage of CSF that may contribute to serious adverse health consequences, including death.
Coumadin (warfarin sodium) for Injection by Bristol-Myers Squibb: Recall - Particulate Matter07/01/2014 Medical RecallInjected particulate metallic and non-metallic cellulose material can cause serious and potentially fatal adverse reactions such as embolization.
Medical Supply Liquidators Injectable Vitamin Products With a "Sunshine Labs" Label: Warning - Products Not FDA Approved06/30/2014 Medical RecallAll lots of non-expired products being recalled.
Lidocaine Viscous: Drug Safety Communication - Boxed Warning Required - Should Not Be Used to Treat Teething Pain06/26/2014 Medical RecallToo much viscous lidocaine given to infants and young children can result in seizures, severe brain injury, and problems with the heart.
Over-The-Counter Topical Acne Products: Drug Safety Communication - Rare But Serious Hypersensitivity Reactions06/25/2014 Medical RecallReactions may include throat tightness; difficulty breathing; feeling faint; or swelling of the eyes, face, lips, or tongue.
Olmesartan: Drug Safety Communication - FDA Review Finds Cardiovascular Risks for Diabetics Not Conclusive06/24/2014 Medical RecallRecommendations for use remain the same; label updates required.
Red Yeast Rice by Doctor’s Best: Recall - Undeclared Lovastatin06/24/2014 Medical RecallUse could result in serious muscle injury, particularly if taking with prescription “statins”; patients with pre-existing liver disease may be at an increased risk for liver injury.
Big Sky Diagnostic Imaging, LLC in Butte, Montana: FDA Safety Communication - Mammography Problems06/23/2014 Medical RecallPatients who had a mammogram performed at Big Sky Diagnostic Imaging should speak to their health care providers about whether their mammograms need to be repeated.
Testosterone Products: FDA/CDER Statement - Risk of Venous Blood Clots06/20/2014 Medical RecallWarning about venous thromboembolism, including deep vein thrombosis and pulmonary embolism.
ConvaTec, Inc., Flexi-Seal CONTROL Fecal Management System Kit: Class I Recall - Not Cleared for Marketing06/20/2014 Medical RecallReports of 12 serious injuries and one death.
Docetaxel: Drug Safety Communication - May Cause Symptoms of Alcohol Intoxication06/20/2014 Medical RecallDocetaxel contains alcohol, which affects the central nervous system.
HydroFinity Hydrophilic Guidewires by NDC/Covidien: Recall - Outer Jacket Damage06/20/2014 Medical RecallDamage to the jacket can result in embolization of polymer, potentially leading to vessel occlusion or damage.
Weight Loss Products: Immediate Public Notification: Undeclared Drug Ingredients06/19/2014 Medical RecallProducts may substantially increase blood pressure and/or pulse rate in some patients.
Marcaine (Bupivacaine HCI Injection, USP), 0.5 percent, 30 ML, Single-Dose, Preservative-Free Vial: Recall - Visible Particulates06/18/2014 Medical RecallInjected particulate could result in blocked administration of the drug to the patient, causing a delay in therapy.
May 201406/13/2014 Medical RecallSafety Labeling Changes includes 37 products with revisions to Prescribing Information. Posted 06/13/2014.
Captomer and Captomer-250 by Thorne Research: FDA Warning - Potential Health Risks06/13/2014 Medical RecallFDA advises consumers to avoid all products offered over-the-counter (OTC) for chelation or detoxification.
Smiths Medical Portex Low Dead Space Connector with Sideport, 3.5mm: Class I Recall- One Lot Mislabeled06/13/2014 Medical RecallOne lot of 3.0mm sized connectors were placed in packages labeled as 3.5mm.
Advocate Redi-Code+ Blood Glucose Test Strips by Diabetic Supply of Suncoast: Recall- Labeling Error06/11/2014 Medical RecallDelayed or inappropriate treatment of hyperglycemic or hypoglycemic states due to missed/delayed detection could lead to serious health consequences, including death.
La Jiao Shou Shen: Public Notification - Undeclared Drug Ingredient06/11/2014 Medical RecallCancer-causing risk in addition to increased blood pressure and/or pulse rate.
Male Sexual Enhancement Products: Immediate Public Notification: Undeclared Drug Ingredients06/03/2014 Medical RecallRisk of interaction with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels.
Soliris (eculizumab) Concentrated Solution for IV Infusion by Alexion: Recall - Visible Particulates06/02/2014 Medical RecallParticulates could cause blockage of blood flow, which could be life-threatening.
Advanced Sterilization Products Sterrad Cyclesure 24 Biological Indicator: FDA Safety Communication - Product Shortage05/23/2014 Medical RecallHospitals should prioritize use of existing supplies based on patients with the most critical need until supplies are able to meet demand.
Fisher and Paykel Healthcare, Ltd., Infant Nasal CPAP Prongs: Class I Recall - Prongs May Detach from Nasal Tubing and Interrupt Therapy05/23/2014 Medical RecallDevice malfunction may lead to low blood oxygen (hypoxemia), and a risk of choking and airway obstruction.
NaturaLyte Liquid Bicarbonate Concentrate: Recall - Potential Health Risk05/22/2014 Medical RecallBacterial contamination of the dialysate may lead to bacteremia or systemic infection.
Baxter ABACUS TPN Calculation Software: Class I Recall - Software Errors May Cause Toxic/Overdose Symptoms05/22/2014 Medical RecallA fatal outcome is possible, especially with the high risk population.
Alaris Pump Module (Model 8100), Version 9.1.18 Software by CareFusion 303, Inc: Class I Recall - May Not Properly Delay an Infusion05/21/2014 Medical Recall"Delay Until" Option or "Multidose" feature software failure may result in unintented infusion start time.
Ventlab Resuscitator Bags: Recall - Possible Health Risk05/16/2014 Medical RecallMay result in delay of treatment, life threatening health consequences that include hypoxia and hypoventilation.
MV5 Days: Public Notification - Undeclared Drug Ingredient05/16/2014 Medical RecallMay interact with nitrates found in some prescription drugs, and may lower blood pressure to dangerous levels.
Asset Bold: Public Notification - Undeclared Drug Ingredient05/16/2014 Medical RecallRisk of increased blood pressure and/or pulse rate.
April 201405/16/2014 Medical RecallDrug Safety Labeling Changes, April 2014
Labetalol Hydrochloride Injection 100 MG/20 ML (5MG/ML), 20 ML, Multidose Vial by Hospira: Recall - Visible Particulates05/16/2014 Medical RecallRisk of injection site reactions and local irritation in the blood vessels, tissues and organs or delay in therapy.
Eszopiclone Containing Sleep Aids: Drug Safety Communication - Can Cause Next-Day Impairment05/15/2014 Medical RecallFDA recommends a decreased starting dose for both women and men.
Dobutamine Injection (250mg/20mL)/Hospira: Recall - Visible Particulates05/15/2014 Medical RecallInjected particulate matter may result in local inflammation, phlebitis, and/or low level allergic response.
Pradaxa (dabigatran): Drug Safety Communication - Lower Risk for Stroke and Death, but Higher Risk for GI Bleeding Compared to Warfarin05/13/2014 Medical RecallStudy finds lower risk of clot-related strokes, bleeding in brain, and death for Pradaxia versus warfarin, but increased risk of major GI bleeding.
Datascope Corp/MAQUET, Certain Intra-Aortic Balloon Pumps: Recall - Potential Mechanical Failure of Power Supply Fan Assembly05/12/2014 Medical RecallFailure could result in the balloon pump shutting down without warning, which could result in worsened heart failure, decreased blood flow to the heart, and/or decreased blood flow to the body and brain.
Asset Bee Pollen: Public Notification - Undeclared Drug Ingredient05/12/2014 Medical RecallSibutramine is known to substantially increase blood pressure and/or pulse rate in some patients.
Alere INRatio2 PT/INR Professional Test Strips: Recall - Higher INR when Performed by Central Laboratory05/07/2014 Medical RecallTherapeutic or near therapeutic INR with the test strips but a significantly higher INR when performed by a central laboratory.
African Black Ant, Black Ant, and Mojo Risen by Eugene Oregon, Inc: Recall - Undeclared Drug Ingredient05/07/2014 Medical Recallmay contain undeclared amounts of sildenafil and tadalafil.
Slim Trim U: Public Notification - Undeclared Drug Ingredient05/06/2014 Medical RecallRisk of increased blood pressure and/or pulse rate.
Natural Body Solution: Public Notification - Undeclared Drug Ingredient05/06/2014 Medical RecallRisk of increased blood pressure and/or pulse rate.
Abbott Acclaim and Hospira Acclaim Encore Infusion Pumps by Hospira, Inc: Class I Recall - Broken Door Assemblies05/02/2014 Medical RecallMay Result in Over-Infusion or Delay of Therapy.
Gemstar Docking Station by Hospira, Inc: Class I Recall - Potential for Error or Failure to Power Up05/02/2014 Medical RecallA delay or interruption in therapy has a worst case potential to result in significant injury or death.
Sigma Spectrum Infusion Pumps with Master Drug Library by Baxter Healthcare: Class I Recall - System Error May Interrupt or Delay Therapy05/02/2014 Medical RecallPump may stop the infusion, requiring a clinician to reset the alarm, reprogram the pump, and confirm the infusion is running properly.
Flawless Beauty and Skin Products: Recall - Unapproved Drugs04/30/2014 Medical RecallRisks include unknown quality, safety, and efficacy.
GenStrip Blood Glucose Test Strips by Shasta Technologies: FDA Safety Communication - May Report False Results04/29/2014 Medical RecallRecent FDA inspection of manufacturer found extensive violations of federal regulations intended to assure the quality of product.
HeartWare, Inc., Heartware Ventricular Assist System: Class I Recall - Locking Mechanism of Pump Driveline Connector May Fail to Engage04/29/2014 Medical RecallFailure could result in the pump stopping and lead to serious adverse health consequences, including death.
Super Arthgold by Nano Well-being Health: Recall - Undeclared Drug Ingredients04/24/2014 Medical RecallRisk of myocardial infarction, stroke, congestive heart failure, renal toxicity, and bleeding, ulceration, or perforation of the stomach or intestines.
Epidural Corticosteroid Injection: Drug Safety Communication - Risk of Rare But Serious Neurologic Problems04/23/2014 Medical RecallInjection of corticosteroids into the epidural space of the spine may result in loss of vision, stroke, paralysis, and death.
Marcaine (Bupivacaine HCI Injection, USP) 0.25 percent, 10 ml, Single-Dose, Preservative-Free Vial: Recall - Visible Particulates04/22/2014 Medical RecallInjected particulate could result in local inflammation, mechanical disruption of tissue or immune response to the particulate.
Thinogenics Products by Nature’s Universe: Recall - Undeclared Drug Ingredient04/18/2014 Medical RecallUse of undeclared sibutramine can lead to increased risk of seizures, heart attacks, arrhythmia and stroke.
Propofol Injectable Emulsion, USP by Hospira: Recall - Visible Particulates04/18/2014 Medical RecallInjected particulate matter may result in local inflammation, phlebitis, and/or low level allergic response through mechanical disruption of tissue or immune response to the particulate.
S.W.A.G: Public Notification - Undeclared Drug Ingredient04/18/2014 Medical RecallContains undeclared Sildenafil, which may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.
CUBICIN (daptomycin for injection) by Cubist Pharmaceuticals: Recall - Presence of Particulate Matter04/18/2014 Medical RecallPotential risk of thromboembolism, pulmonary emboli, phlebitis, mechanical block of the capillaries or arterioles, activation of platelets, subsequent generation of microthrombi, and emboli.
Lidocaine HCI Injection, USP, by Hospira: Recall - Visible Particulates04/18/2014 Medical RecallRisk of local inflammation, and/or mechanical disruption of tissue or immune response to the particulate, and/or a delay in therapy.
Laparoscopic Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication - Use Discouraged Due to Increased Risk in Women With Uterine Fibroids04/17/2014 Medical RecallIf laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis.
ARKON Anesthesia Delivery System with Version 2.0 Software by Spacelabs Healthcare: Class I Recall - Software Defect May Cause System to Stop Working04/16/2014 Medical RecallDefect may cause serious adverse health consequences, including hypoxemia and death.
Infinity: Public Notification - Undeclared Drug Ingredient04/11/2014 Medical RecallUse may increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
Lite Fit USA: Public Notification - Undeclared Drug Ingredient04/11/2014 Medical RecallUse may increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
March 201404/11/2014 Medical RecallSafety Labeling Changes includes 30 products with revisions to Prescribing Information. Posted 04/11/2014.
Covidien Pipeline Embolization Device and Alligator Retrieval Device: Recall - Coating on Delivery Wire Could Delaminate04/11/2014 Medical RecallUse of affected products could potentially lead to embolic occlusion in the cerebral vasculature, with the risk of stroke and/or death.
Zi Xiu Tang Bee Pollen Capsules by Guangzhou Zi Xiu Tang Biotechnology Co., Ltd: Warning - Undeclared Drug Ingredients04/08/2014 Medical RecallRisk of increased blood pressure and/or pulse rate.
PS500 Power Supply Unit by Dräger: Recall - Early Depletion of Battery Charge04/02/2014 Medical RecallBattery depletion will require manual ventilation until the device is connected to main power.
Revatio (sildenafil): Drug Safety Communication - FDA clarifies Warning About Pediatric Use for Pulmonary Arterial Hypertension03/31/2014 Medical RecallHealth care professionals must consider whether the benefits of treatment with the drug are likely to outweigh its potential risks for each patient.
Nova Products, Inc. Dietary Supplements: Recall - Undeclared Drug Ingredients03/31/2014 Medical RecallSildenafil and tadalafil can interact with nitrates found in some prescription drugs (such as nitroglycerin), resulting in decreased blood pressure.
Alli (60 mg orlistat capsules) by GlaxoSmithKline: Recall - Product Tampering03/28/2014 Medical RecallSome packages of the product were tampered with and may contain product that is not authentic.
Bella Vi Brand Products by Pure Edge Nutrition: Recall - Undeclared Drug Ingredients03/26/2014 Medical RecallSibutramine can increase blood pressure and/or pulse rate in some patients and may present a risk for those with a history of coronary artery disease, congestive heart failure, arrhymias or stroke.
New Life Nutritional Center Dietary Supplements: Recall - Undeclared Drug Ingredients03/26/2014 Medical RecallUndeclared sibutramine and phenolphthalein make these products unapproved new drugs for which safety and efficacy have not been established.
Pleo Homeopathic Drug Products by Terra-Medica: Recall - Potential for Undeclared Penicillin03/21/2014 Medical RecallExposure to penicillin can result in a range of allergic reactions from mild rashes to severe and life-threatening anaphylactic reactions.
February 201403/19/2014 Medical RecallDrug Safety Labeling Changes, February 2014
Vitaccino Coffee: Public Notification - Undeclared Drug Ingredient03/19/2014 Medical RecallSibutramine is known to substantially increase blood pressure and/or pulse rate in some patients, and may also present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
Playtex Nurser Deluxe Double Electric Breast Pump: Recall - Potential for Electric Shock03/19/2014 Medical RecallThe casing on some AC/DC power adapters may become loose and separate, resulting in a potential for electric shock.
Hospira Hemostat Dual Channel Plum Set: Recall-Risk of over-delivery of blood products03/18/2014 Medical RecallOver-delivery of blood products in the populations at greatest risk may result in injuries that require medical intervention.
FreeStyle and FreeStyle Flash Blood Glucose Meter by Abbott: Recall - May Produce Mistakenly Low Blood Glucose Results03/17/2014 Medical RecallSymptoms of high blood sugar include excessive thirst, excessive urination, blurred vision, weakness, nausea, vomiting and abdominal pain.
McKesson Technologies Anesthesia Care: Recall – Patient Case Data May Not Match Patient Data03/15/2014 Medical RecallClass 1 recall of computer-based system.
VPRIV (velaglucerase alfa for injection): Recall - Visible Particulate Matter03/14/2014 Medical RecallRisk of rare but serious adverse events associated with infusion containing particulates.
Reumofan Plus: Recall - Undeclared Drug Ingredient03/14/2014 Medical RecallUPDATED 03/14/2014. Pain Free by Nature is voluntarily recalling all lots of Reumofan Plus Tablets. Originally posted 06/01/2012.
Merit Medical Systems, Custom Procedural Trays/Kits Containing 1 percent Lidocaine HCl Injection, USP, 10mg/mL: Recall - Particulates Found in Hospira supplied Lidocaine03/14/2014 Medical RecallPresence of oxidized stainless steel particulate may put a patient at risk from strong magnetic field exposure such as MRI, and other adverse events resulting in serious life-threatening complications.
Greatbatch, Inc. Standard Offset Cup Impactors: Recall - Sterilization Recommendation in Instructions Do Not Meet Sterility Assurance Requirements03/12/2014 Medical RecallLack of sterility assurance has the potential to result in surgical infection.
Effexor XR 150 Mg Extended-Release Capsules (Pfizer) and Venlafaxine HCl 150 Mg Extended-Release Capsules (Greenstone): Recall - Possible Presence of Tikosyn Capsules03/07/2014 Medical RecallThe use of Tikosyn by an Effexor XR/Venlafaxine HCl patient could cause serious adverse health consequences that could be fatal.
Doribax (doripenem): Drug Safety Communication - Risk When Used to Treat Pneumonia on Ventilated Patients03/07/2014 Medical RecallIncreased risk of death and lower clinical cure rates compared to use of imipenem and cilastatin.
DIANEAL PD-2 Peritoneal Dialysis Solution with 1.5 Percent Dextrose 6000mL: Recall - Contamination With Mold03/07/2014 Medical RecallAdministration of a product contaminated with mold could result in life-threatening fungal peritoneal infection or sepsis.
HeartMate II LVAS Pocket System Controller by Thoratec Corporation: Medical Device Correction - Updated Labeling and Training Materials03/05/2014 Medical RecallReports of four deaths and five incidents of loss of consciousness or other symptoms of hypoperfusion, occurring in patients who were converted to the Pocket Controller after being originally trained on an older model.
GE Healthcare Resuscitation Systems: Class I Recall - Oxygen and Air Inlet Fittings Reversed During Assembly02/28/2014 Medical RecallRecalled products may interfere with oxygen delivery, resulting in inaccurate oxygen regulation in neonates. This may cause death in neonates, particularly those who are critically ill.
ACME Monaco Guidewire .035x150 3MMJ TCFC, Item 88241 by Medline Industries: Class I Recall - Potential for Coating to Flake Off02/25/2014 Medical RecallUse of this recalled product may result in serious adverse health consequences.
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port (with and without Preloaded Stylet) by Teleflex Medical – Class I Recall: Potential Kinking During Patient Use02/24/2014 Medical RecallIf a tracheal tube kinks, it can deprive the patient of adequate ventilation causing serious patient injury including hypoxic injury and/or anoxia, and death.
Etomidate Injection/Pfizer-Mylan: Recall - Presence of Particulate Matter and/or Illegible and Missing Lot Number and/or Expiry Date02/20/2014 Medical RecallIntravenous administration of particles may lead to impairment of microcirculation, phlebitis, infection, embolism and subsequent infarction.
Trilogy Ventilator Models 100, 200 and 202 by Philips Respironics: Recall - Failure to Deliver Mechanical Breaths02/20/2014 Medical RecallPotential ventilator failure and reduced alarm functionality may result in serious adverse health consequences or death.
Acetylcysteine Solution 10 Percent: Recall - Glass Particles in Product02/15/2014 Medical RecallUse of an inhaled product with glass particles has potential to cause choking which could be life-threatening. Aerosolization of small glass particles in airways could result in recurrent infections.
Reduce Weight Fruta Planta: Recall - Undeclared Drug Ingredient02/14/2014 Medical RecallConsumption of this product could include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use.
L-citrulline by Medisca: Alert - Potentially Subpotent Product02/14/2014 Medical RecallSubpotent L-citrulline in patients with certain urea cycle defects can lead to high ammonia levels, which is serious and potentially life-threatening.
Saxagliptin (marketed as Onglyza and Kombiglyze XR): Drug Safety Communication - FDA to Review Heart Failure Risk02/11/2014 Medical RecallFDA has requested clinical trial data from the manufacturer of saxagliptin to investigate a possible association between use of the type 2 diabetes drug and heart failure.
Calcium gluconate 10 percent Injections by Rx Formulations: Recall - Microbial Contamination02/07/2014 Medical RecallFDA testing confirmed the presence of gram-positive rod bacteria in the product, which can cause infection in patients.
Testosterone Products: Drug Safety Communication - FDA Investigating Risk of Cardiovascular Events01/31/2014 Medical RecallFDA assessing safety issues based on two separate studies that suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy.
Mega Slim Herbal Appetite Management Pills by YoungYou International: Recall - Presence of DMAA01/31/2014 Medical RecallDMAA may cause a rise in blood pressure or other cardiovascular problems such as shortness of breath, tightening in the chest or heart attack.
Trufill n-BCA Liquid Embolic System by Codman Neuro: Recall - Incorrect Instructions For Use01/22/2014 Medical RecallIncorrectly mixed product can result in the liquid mixture solidifying too slowly and could result in significant impact to the patient, including neurological deficits, pulmonary emboli and possibly death.
Dream Body Slimming Capsule: Public Notification - Undeclared Drug Ingredient01/22/2014 Medical RecallSibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
Magic Slim: Public Notification - Undeclared Drug Ingredient01/22/2014 Medical RecallSibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
StemAlive 90 Capsules: Recall - Contains Undeclared Milk01/20/2014 Medical RecallRisk of serious or life-threatening allergic reaction.
Rohto Eye Drops - Mentholatum: Recall - Sterility Control Review01/17/2014 Medical RecallProduction facility in Vietnam reviewing manufacturing sterility controls.
Acetaminophen Prescription Combination Drug Products with more than 325 mg: FDA Statement - Recommendation to Discontinue Prescribing and Dispensing01/15/2014 Medical RecallInadvertent overdose from prescription combination drugs containing acetaminophen accounts for nearly half of all cases of acetaminophen-related liver failure in the United States, some of which result in liver transplant or death.
t:slim Insulin Cartridges by Tandem Diabetes Care: Recall - Potential for Cartridge Leak01/14/2014 Medical RecallCartridge leak could potentially result in the device delivering too much or too little insulin.
Pro ArthMax by Human Science Foundation: Recall - Undeclared Drug Ingredients01/14/2014 Medical RecallUndeclared Chlorzoxazone, Nefopam, Diclofenac, Ibuprofen, Naproxen, and Indomethacin. Pro ArthMax has a reasonable probability of resulting in fatal adverse events.
Boost Ultra, XZone Gold, Sexy Monkey, Triple MiracleZen Platinum, Magic for Men,"New" Extenze, and New XZen Platinum Marketed as Dietary Supplements: Recall - Undeclared Drug Ingredients01/10/2014 Medical RecallAnalysis found these products to contain undeclared Sildenafil and/or Tadalafil, may interact with nitrates found in some prescription drugs, and may lower blood pressure to dangerous levels.
Puritan Bennett 840 Series Ventilator by Covidien - Class I Recall - Software Problem01/10/2014 Medical RecallVentilator may stop functioning, triggering the safety alarm and causing the patient to suddenly be required to breathe on his or her own.
December 201301/10/2014 Medical RecallSafety Labeling Changes includes 39 products with revisions to Prescribing Information.
Sodium Phosphate Over-the-Counter Products: Drug Safety Communication - Possible Harm From Exceeding Recommended Dose01/08/2014 Medical RecallReports of severe dehydration and changes in the levels of serum electrolytes from taking more than the recommended dose, resulting in serious adverse effects, in some cases resulting in death.
Truebalance and Truetrack Blood Glucose Meters by Nipro Diagnostics: Recall - Incorrect Factory-set Measure01/08/2014 Medical RecallIf a consumer were not to notice the incorrect unit of measure, it is possible that the meter result could be read as a lower than expected blood glucose result.
SafeSpout and SafeShower Filtration Products by Nephros: Class I Recall - Exposure to Bacteria or Virus01/07/2014 Medical RecallThe fiber filter or the sealing compound, holding the fiber in place, could break apart, exposing patients to bacteria or viruses, which could result in infection or death.
Nephros Filtration Products: Class I Recall - Labeling Promoting Medical Claims01/07/2014 Medical RecallPromotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device.
CLINIMIX and CLINIMIX E Injection/Baxter: Recall - Particulate Matter in Products01/06/2014 Medical RecallIf infused, particulate matter may result in blockages of blood vessels, which can result in stroke, heart attack, or damage to other organs such as the kidney or liver.
CO2 Multi Absorber by Vital Signs Devices: Field Corrective Action - Loss of Anesthetic Gases, Ventilation and Oxygenation01/01/2014 Medical RecallA potential safety issue due to air leakage associated with the CO2 Multi Absorber.
Baxter 5 Percent Dextrose Injection, USP And 0.9 Percent Sodium Chloride Injection, USP Intravenous (IV) Solutions: Recall - Particulate Matter In Solution12/27/2013 Medical RecallInjecting a product containing particulate matter may result in blockages of blood vessels, which can result in stroke, heart attack or damage to other organs such as the kidney or liver.
Burn 7 Capsules by Deseo Rebajar: Recall - Undeclared Drug Ingredient12/24/2013 Medical RecallUndeclared Sibutramine, known to substantially increase blood pressure and/or pulse rate in some patients.
Lidocaine HCl Injection 2%, 5 ml Vial by Hospira: Recall - Presence of Particulate Matter12/24/2013 Medical RecallIf infused, particulate matter could lead to local inflammation, tissue trauma, mechanical disruption of tissue, and/or local granuloma formulation.
Muscle Growth Product Called Mass Destruction: FDA Health Risk Warning - Undeclared Ingredients12/23/2013 Medical RecallThe product is labeled to contain at least one synthetic anabolic steroid and has been linked to at least one reported serious illness.
Abrams Royal Pharmacy Sterile Products - Recall - Lack of Sterility Assurance12/19/2013 Medical RecallUse of Microbial contamination in products intended to be sterile can put patients at risk for serious, potentially life-threatening infections.
Methylphenidate ADHD Medications: Drug Safety Communication - Risk of Long-lasting Erections12/17/2013 Medical RecallProlonged erections (priapism) can lead to permanent damage to the penis.
Soliris (Eculizumab) Concentrated Solution for Intravenous Infusion by Alexion: Recall - Visible Particles12/16/2013 Medical RecallTwo lots were found to contain visible particles. Particulates could cause blockage of flow of blood in vessels, which could be life-threatening.
Nipple Aspirate Test: Safety Communication - Breast Cancer Screening Test Is Not An Alternative To Mammography12/12/2013 Medical RecallMisleading claims about a nipple aspirate test may lead patients to not get mammograms and/or other needed breast imaging tests or biopsies. This may lead to serious adverse health consequences.
Onfi (clobazam): Drug Safety Communication - Risk of Serious Skin Reactions12/03/2013 Medical RecallCases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) Reported.
HeartStart Automated External Defibrillators (AED) From Philips Healthcare: Safety Communication - Failure Of An Electrical Component That Could Cause AEDs To Fail To Deliver Appropriate Shock12/03/2013 Medical RecallWhen normal heart rhythms are not restored quickly, sudden cardiac arrest can cause death.
Hydravax Dietary Supplement by IQ Formulations: Recall - Possible Undeclared Drug Ingredient12/01/2013 Medical RecallSample from one lot of Hydravax revealed the presence of a diuretic. Possible effects of using a diuretic include an electrolyte imbalance due to water loss.
FreeStyle and FreeStyle Lite Blood Glucose Test Strips by Abbott: Recall - Erroneously Low Blood Glucose Results11/28/2013 Medical RecallFalsely low blood glucose results can lead patients to try to raise their blood glucose when it is unnecessary, or to fail to treat elevated blood glucose due to a falsely low reading.
Nitroglycerin in 5% Dextrose Injection by Baxter: Recall - Particulate Matter11/27/2013 Medical RecallVoluntary recall of one lot due to particulate matter found in one vial. If infused, particulate matter could lead to potential venous and/or arterial thromboembolism.
Spacelabs Healthcare, Inc., Spacelabs Anesthesia Workstations and Service Kits: Class I Recall - Bag-to-Vent Switch in CAS I/II Absorbers May Fail11/26/2013 Medical RecallPotential for a large leak from the absorber circuit while operating in bag mode and could impede the ability to provide ventilation in bag mode.
CLR Medicals International Inc. Viscoelastic Products: Recall - Quality System Deficiencies And Lack Of Premarket Approval (PMR)11/26/2013 Medical RecallClinical consequences associated with use of the contaminated and/or adulterated products may include intraocular infection, inflammation and elevated intraocular pressure.
Rosiglitazone-containing Diabetes Medicines: Drug Safety Communication - Removal of Some Prescribing and Dispensing Restrictions11/25/2013 Medical RecallHealth care professionals, pharmacies, and patients will no longer be required to enroll in the rosiglitazone REMS program to be able to prescribe, dispense, or receive rosiglitazone medicines.
Hospira GemStar Infusion System: Class I Recall - Pressure Sensor Calibration Drift11/25/2013 Medical RecallMay result in a delay, interruption or over-infusion in therapy, which have a worst case potential to result in significant injury or death depending on the drug and the dosage administered.
Meridian Medical Technologies Auto-Injectors: Extension of Expiration Dates11/22/2013 Medical RecallFDA is currently reviewing data for the potential use of these auto-injectors beyond their labeled expiration dates, in order to mitigate any potential shortages.
Adipotrim XT by Deseo Rebajar: Recall - Undeclared Drug Ingredient11/21/2013 Medical RecallUndeclared Fluoxetine, a selective serotonin reuptake inhibitor (SSRI). Use of SSRIs have been associated with serious side effects including suicidal thinking, abnormal bleeding, and seizures.
Lexiscan (regadenoson) and Adenoscan (adenosine): Drug Safety Communication - Rare but Serious Risk of Heart Attack and Death11/20/2013 Medical RecallCases of myocardial infarction and death have occurred following the administration of Lexiscan (regadenoson) injection or Adenoscan (adenosine) infusion.
P-Boost, NatuRECT by Tendex: Recall - Undeclared Drug Ingredient11/20/2013 Medical RecallUndeclared tadalafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to unsafe levels.
RezzRX: Recall - Undeclared Drug Ingredients11/19/2013 Medical RecallUndeclared hydroxylthiohomosildenafil and aminotadalafil (PDE-5) inhibitors may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to unsafe levels.
Rhino 5 Plus, Maxtremezen and Extenzone: Recall - Undeclared Drug Ingredients11/19/2013 Medical RecallUndeclared Desmethylcarbondenafil, a posphodiesterase (PDE-5) inhibitor, and dapoxetine, an ingredient not approved by the FDA, may present a health risk which could be life threatening.
Nature's Pharmacy and Compounding Center Sterile Compounded Products: Recall - Lack of Sterility Assurance11/16/2013 Medical RecallIn the event a sterile product is compromised, patients are at risk for very serious infections.
New Reliance Traders, Inc. Special Eyeliner: Recall - Elevated Lead Levels11/16/2013 Medical RecallRecent analysis of the product found that the products contained lead levels high as 167387 parts per million (ppm)
Medtronic Guidewires: Recall - Potential For Coating On Surface To Delaminate And Detach11/16/2013 Medical RecallSome Medtronic models of its guidewires from recent lots have the potential for the coating on their surface to delaminate and detach.
VitaliKOR Fast Acting: Recall - Undeclared Drug Ingredients11/15/2013 Medical RecallUndeclared Vardenafil and Tadalafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to unsafe levels.
Over-the-Counter Topical Antiseptic Products: Drug Safety Communication - FDA Requests Label Changes and Single-Use Packaging to Decrease Risk of Infection11/13/2013 Medical RecallClinical infections have also been reported to FDA, leading to some product recalls. The reported outcomes ranged from localized infections at injection sites to systemic infections that resulted in death.
Vega One Nutritional Shakes and Vega Sport Performance Protein: Recall - Traces of Antibiotic11/12/2013 Medical RecallRisk of aplastic anemia and allergic reactions.
OxyElite Pro Dietary Supplements by USP Labs: Recall - Products Linked to Liver Illnesses11/10/2013 Medical RecallThe products contained aegeline, a new dietary ingredient that lacks a history of use or other evidence of safety.
Baylis Medical TorFlex Transseptal Guiding Sheath Kit: Class I Recall - Sheath Could Remove Particulate11/06/2013 Medical RecallParticulate could potentially migrate into a patient’s bloodstream.
Low Molecular Weight Heparins: Drug Safety Communication - Recommendations to Decrease Risk of Spinal Column Bleeding and Paralysis11/06/2013 Medical RecallAll anticoagulants carry the risk of causing epidural or spinal hematomas when used in conjunction with epidural/spinal anesthesia or spinal puncture.
Edwards Lifesciences LLC, EMBOL-X Glide Protection System: Class I Recall - Deformed Cannula Tip11/04/2013 Medical RecallUse of defective product may lead to tip separation and embolization.
Perrigo Acetaminophen Infant Suspension Liquid: Recall - Potential Defect with Co-packaged Oral Syringe11/02/2013 Medical RecallUsing an oral syringe without dose markings can result in inaccurate dosing, especially in infants who could mistakenly get too high a dose. Posted 11/02/2013
September 201311/01/2013 Medical RecallSeptember 2013 drug safety labeling changes
Potiga (Ezogabine): Drug Safety Communication - Linked To Retinal Abnormalities And Blue Skin Discoloration11/01/2013 Medical RecallUPDATE: Boxed Warning and other labeling changes approved.
PENTAX Medical Gas/Water Valves, Model OF-B194: Recall - Manufacturing Defect11/01/2013 Medical RecallMay prevent users from turning off CO2 gas flow during an endoscopic procedure, leading to risk of peritonitis, perforations, sepsis, death, and bowel perforations requiring surgical repair.
MedStream Programmable Infusion Pump and Refill Kits by Codman and Shurtleff: Class 1 Recall - Drug Over Infusion10/23/2013 Medical RecallAir in the pump reservoir may release a higher dosage of drug than expected, leading to drug overdose.
Specialty Medicine Compounding Pharmacy Certain Unexpired Compounded Sterile Products: Recall - Particulate Matter Found in Vials10/21/2013 Medical RecallIf there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections. Posted 10/21/2013
Bard LifeStent Solo Vascular Stent: Class 1 Recall - Failure to Deploy10/18/2013 Medical RecallSerious adverse health consequences, including complications of bleeding, loss of limb, heart attack, or stroke.
Albuterol Sulfate Inhalation Solution, 0.083 percent (Nephron Pharmaceuticals): Recall - Aseptic Processing Simulation Results10/17/2013 Medical RecallFinding of bacterial growth.
St. Jude Amplatzer Atrial Septal Occluder (ASO): Safety Communication - Reports of Tissue Erosion10/17/2013 Medical RecallTissue surrounding the Amplatzer ASO can break down (erode) and result in life-threatening emergencies that require immediate surgery.
Engström Ventilator, Aespire View, Aisys, And Avance Anesthesia Machines: Voluntary Field Corrective Action - Potential Safety Issue10/16/2013 Medical RecallMay result in the inability to access certain menu functions which could possibly lead to delay in treatment.
Avance, Aisys And Avance CS2 Anesthesia Delivery Systems: Voluntary Field Corrective Action - Potential Safety Issue10/15/2013 Medical RecallA unique sequence of inputs and a collapsed bellow could result in delivery of higher-than-expected tidal volume.
Inclusig (Ponatinib): Drug Safety Communication - Increased Reports Of Serious Blood Clots In Arteries And Veins10/11/2013 Medical RecallHealth care professionals should consider for each patient, whether the benefits of Iclusig treatment are likely to exceed the risks of treatment.
Perfect Body Solutions and Burn 7: Public Notification - Undeclared Ingredients10/10/2013 Medical RecallMay increase blood pressure and/or pulse rate and can present a significant risk for patients with a history certain cardiovascular conditions or stroke.
Dr. Mao Slimming Capsules: Public Notification - Undeclared Ingredients10/10/2013 Medical RecallMay increase blood pressure and/or pulse rate and can present a significant risk for patients with a history certain cardiovascular conditions or stroke.
Bella Vi Insane Amp’d And Bella Vi Amp’d Up: Public Notification - Undeclared Ingredients10/10/2013 Medical RecallMay increase blood pressure and/or pulse rate and can present a significant risk for patients with a history certain cardiovascular conditions or stroke.
Be Inspired: Public Notification - Undeclared Ingredients10/10/2013 Medical RecallMay increase blood pressure and/or pulse rate and can present a significant risk for patients with a history certain cardiovascular conditions or stroke.
Slim Fortune, Lidiy And Slim Expert Dietary Supplement: Recall - Undeclared Ingredients10/09/2013 Medical RecallMay substantially increase blood pressure and/or pulse rate or present a significant risk for patients with a history of certain cardiovascular conditions or stroke.
Cefepime For Injection, USP And Dextrose Injection, USP By B. Braun Medical Inc.: Recall - Visible Particulate Matter10/08/2013 Medical RecallMay illicit inflammatory responses, both chronic and acute, and may be life threatening.
OxyElite Pro: Health Advisory - Acute Hepatitis Illness Cases Linked To Product Use10/08/2013 Medical RecallFDA advises consumers to stop using products labeled OxyElite Pro while the investigation continues.
Fabius Anesthesia Machines: Recall - Did Not Pass High Voltage Test Portion Of Final Production Test10/08/2013 Medical RecallIn extreme cases, may cause a failure of the automatic ventilation function of the device.
Breast Health Test and Mammary Aspiration Specimen Cytology Test: Recall - Instructions For Use, Promotional Claims and FDA Clearance Concerns10/05/2013 Medical RecallAtossa will remove existing product from the market until concerns are addressed.
1% Lidocaine HCL Injection By Hospira: Recall - Presence Of Dark Particulate10/05/2013 Medical RecallMay result in local inflammation, phlebitis, and/or low-level allergic response, and could block administration of the drug to the patient, causing a delay in therapy.
Emergency Cricothyrotomy Kit By H&H Medical Corporation: Recall - Defective Cuff Balloon On Endotracheal Airway10/04/2013 Medical RecallDefect due to a reduction in package density, a higher than average dose of gamma sterilization, and the occasional slippage of a protective silicon sleeve during shipping.
Metoclopramide Injection And Ondansetron Injection by Hospira: Recall - Glass Strand Particulates Caused By Glass Supplier10/02/2013 Medical RecallAdministration of an injectable with the presence of foreign particulates may result in local inflammation, thrombophlebitis, and/or low-level allergic response.
Virilis Pro, PHUK and Prolifta Capsules : Recall - Undeclared Ingredients10/01/2013 Medical RecallPotential to interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to unsafe levels.
Carefusion Avea Ventilator: Recall - Underreporting Of Tidal Volume If Used In Conjunction With Neonatal Hotwire Flow Sensor10/01/2013 Medical RecallPatients may receive a higher than expected tidal
Afikim Electric Vehicles Issues Nationwide Recall Of Breeze C Scooter: Recall - Potential For Malfunction10/01/2013 Medical RecallMay become unresponsive during operation, resulting in the driver not being able to stop the scooter during operation.
Tygacil (tigecycline): Drug Safety Communication - Increased Risk of Death09/27/2013 Medical RecallBOXED WARNING describes risk for FDA-approved and non-approved uses.
The Compounding Shop: FDA News Release - Lack of Sterility Assurance of Drug Products09/27/2013 Medical RecallUPDATED 09/27/2013. Budesonide solution, used for nasal irrigation, from The Compounding Shop may be contaminated and should not be used or administered to patients. Originally posted 05/08/2013
W.S. Badger Company Daily SPF 30 Kids & Baby Sunscreen Lotion: Recall - Microbial Contamination09/25/2013 Medical RecallLab testing found certain product lots were contaminated with Pseudomonas aeruginosa, Candida parapsilosis and Acremonium fungi.
Arzerra (ofatumumab) and Rituxan (rituximab): Drug Safety Communication - New Boxed Warning, Recommendations to Decrease Risk of Hepatitis B Reactivation09/25/2013 Medical RecallHepatitis B reactivation occurred in patients with prior HBV exposure and later treated with Arzerra & Rituxan. Cases of fulminant hepatitis, hepatic failure, and death reported.
Xzen 1200, Xzen Gold and Xzen XPress: Public Notification - Undeclared Ingredients09/24/2013 Medical RecallMay interact with nitrates found in some prescription drugs lower blood pressure to dangerous levels.
XZone Premium: Public Notification - Undeclared Drug Ingredient09/24/2013 Medical RecallContains contains sildenafil and tadalafil, which may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.
Wood-E: Public Notification - Undeclared Drug Ingredient09/24/2013 Medical RecallContains sildenafil, which may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.
Duragesic (fentanyl) Patches: Drug Safety Communication - Packaging Changes to Minimize Risk of Accidental Exposure09/23/2013 Medical RecallAccidental exposure to fentanyl can cause serious harm and death in children, pets, and others.
Baxter Dual Luer Lock Caps: Class I Recall - Presence of Loose Particulate Matter Found In Packaging09/20/2013 Medical RecallMay result in thrombotic and embolic events, including: pulmonary embolism, myocardial infarction and stroke.
Shou Fu Ti Tun Guo Xiang Xing Jian Fei Jiao Nang: Public Notification - Undeclared Drug Ingredient09/17/2013 Medical RecallMay substantially increase blood pressure and/or pulse rate in some patients and presents a risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
HeartSine Technologies Samaritan 300/300P PAD Public Access Defibrillators: Recall - Power, Battery Issues09/17/2013 Medical RecallTwo separate issues may affect the ability to deliver therapy to a patient in a sudden cardiac arrest event.
Bupivacaine HCL Injection 0.25% (2.5 MG/ML) and Bupivacaine HCL 0.75% (7.5 MG/ML), 30 ML Single-Dose Vials by Hospira, Inc.: Recall- Presence of Particulate Matter09/14/2013 Medical RecallOne lot of each strength recalled, administration of an injectable with the presence of foreign particulates may potentially cause thrombophlebitis, bacteremia, sepsis, and/or endocarditis and death may result.
Creafuse Powder Grape and Creafuse Powder Fruit Punch: Recall - Contains DMAA09/13/2013 Medical RecallIngestion of DMAA can elevate blood pressure and lead to cardiovascular problems.
Leiter's Compounding Pharmacy: Recall - Concerns of Sterility Assurance09/12/2013 Medical RecallUse of a non-sterile injectable product exposes patients to the risk of contracting serious life-threatening infections.
Park Compounding Sterile Medication: Recall – Concerns of Sterility Assurance09/10/2013 Medical RecallIf there is microbial contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening.
Avella Specialty Pharmacy Sterile Medications: Recall - Concerns Of Sterility Assurance At Testing Vendor09/09/2013 Medical RecallIf microbial contamination occurs in medications intended to be sterile, patients are at risk of serious infections that may be life threatening.
Altaire Pharmaceuticals Carboxymethylcellulose Sodium 0.5 Percent Ophthalmic Solution Sold Under Wal-Mart, CVS, and Target Brands: Recall - Preservative May Not Be Effective Through Expiry09/08/2013 Medical RecallPotential risk for eye infection.
University Compounding Pharmacy Injection Products: Recall - Lack of Sterility Assurance09/08/2013 Medical RecallIf there is microbial contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening.
MOTRIN Infants Drops Original Berry Flavor 1/2 fl oz: Recall - Particles Identified09/08/2013 Medical RecallMay contain tiny plastic particles.
Medaus Pharmacy Sterile Compounded Products - Recall: Inability to Confirm Sterility09/05/2013 Medical RecallQuestions Surrounding an Independent Third Party's Sterility Testing
Siemens MicroScan Synergies Plus And MicroScan RapID/S Plus Negative Panels: Class I Recall - False Susceptible And False Intermediate Results09/04/2013 Medical RecallDefect may lead to treatment with an inappropriate antibiotic or a delay in initiating appropriate therapy.
Aminosyn II 10 percent, Sulfite-Free (Hospira): Recall - Particulate Matter Noted in One Lot09/03/2013 Medical RecallParticle confirmed by Hospira as human hair.
Cubicin (daptomycin for injection): Recall - Glass Particulate Matter Present in Four Lots08/29/2013 Medical RecallRisk of thromboembolism and pulmonary emboli, some life-threatening.
Gilenya (fingolimod) - Drug Safety Communication: Investigating Rare Brain Infection08/29/2013 Medical RecallPatient has developed a rare and serious brain infection after taking the drug.
Stryker Spine: Class 1 Recall - OASYS Midline Occiput Plate08/29/2013 Medical RecallPost-operative fracture of the pin that connects the head to the plate body.
Pro Power Max, Evil Root and 72HP By Hardmenstore.com: Recall - Undeclared Ingredient08/28/2013 Medical RecallMay interact with nitrates found in some prescription drugs,lower blood pressure to dangerous levels or cause side effects, such as headaches and flushing.
Wellness Pharmacy, Inc. Products: Recall - Laboratory Results Indicating Microbial Contamination08/27/2013 Medical RecallIf there is microbial contamination in medications intended to be sterile, patients are at risk of serious infections which may be life threatening.
JCB Laboratories Products: Recall - Sterility Assurance at Testing Vendor08/27/2013 Medical RecallIf there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections.
Compounded Sterile Preparations By Park Pharmacy & Compounding Center: Recall - Lack of Sterility Assurance08/27/2013 Medical RecallMethods used by the laboratory to assess sterility may have resulted in pharmacies receiving inaccurate laboratory test results.
Ortiga Contains Hidden Drug Ingredient08/22/2013 Medical RecallFDA laboratory analysis confirmed that Ortiga contains the prescription drug ingredient, diclofenac.
Jack Rabbit Dietary Supplement: Recall - Undeclared Drug Ingredients08/21/2013 Medical RecallUndeclared Sildenafil and Tadalafil may interact with nitrates found in some prescription drugs such as nitroglycerin, and may lower blood pressure to dangerous levels.
Covidien Monoject Prefill Flush Syringes: Recall - Not Subjected To AutoClave Sterilization Process Or Mismatched Syringe Tip Cap, Syringe Label, Filled Volume And Wrapper08/20/2013 Medical RecallHealth risk of life-threatening infection to the blood stream or patency of device may not be maintained and clotting may occur.
Esbelder Man Capsules, Esbelder Fem Capsules, And Esbelder Siloutte Capsules Vitamin Supplements By Herbal Give Care LLC: Recall - Undeclared Ingredients08/20/2013 Medical RecallMay substantially increase blood pressure and/or pulse rate as well as present significant other health risks for patients.
Aidapak Services LLC, Select Repackaged Pharmaceuticals: Recall - Potential Incorrect Labeling08/17/2013 Medical RecallAidapak Services LLC, Specific Unit Dose Repackaged Products: Recall - Potential Incorrect Labeling
Fluoroquinolone Antibacterial Drugs: Drug Safety Communication- Risk for possibly permanent nerve damage08/15/2013 Medical RecallThe risk of peripheral neuropathy occurs only with fluoroquinolones that are taken by mouth or by injection.
Hospira Blood Sets: Recall - Instances Of Outer Wall Of Blood Bags Punctured With Piercing Pin08/14/2013 Medical RecallSpillage of the blood and blood products stored in the bag may result in delay/interruption in therapy or exposure to the healthcare professional.
Iradimed Corporation, MRidium 3860+ Infusion Systems equipped with MRidium 1145 Dose Error Reduction System (DERS) Drug Library Kit: Class I Recall - Potential for Incorrect Recommended Infusion Rate08/12/2013 Medical RecallIncreased risk of over-infusion or under-infusion if the infusion is started with the incorrect rate. This can cause serious adverse health consequences, including death.
Specialty Compounding Sterile Products: FDA Alert - Bacterial Infections08/09/2013 Medical RecallBacterial infections have been potentially associated with contaminated calcium gluconate infusions.
Cordis Optease Retrievable Inferior Vena Cava (IVC) Filter: Recall - Labeling Correction08/08/2013 Medical RecallThe company is making corrections and improvements to the device labeling to minimize likelihood of implanting the filter backwards.
CareFusion Alaris PC unit (model 8015) with version 9.12 Keyboard Processor: Class I Recall - Potential Loss of Communication Between Main Processor and Keyboard08/07/2013 Medical RecallDevice malfunction can result in the sudden unintended discontinuation of medications. This can lead to cause serious adverse health consequences, including death.
Tranquility by Health and Beyond, LLC: Recall - Undeclared Drug Ingredient08/07/2013 Medical RecallConsuming this product potentially could result in dizziness and cause public health risk.
BEST SLIM 40 Pills By CTV Best Group: Recall - Undeclared Ingredients08/06/2013 Medical RecallSibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk.
Bethel Advance And Quick Thin Products By Bethel Nutritional Consulting, Inc.: Recall - Undeclared Ingredients08/06/2013 Medical RecallSibutramine and Phenolphthalein may pose health threats or interact in life-threatening ways with other medications a consumer may be taking.
Benztropine Mesylate Injection (Nexus Pharmaceuticals): Recall - Visible Particulate Matter08/02/2013 Medical RecallRisk of thromboembolism, some life-threatening (such as pulmonary emboli), as well as other serious adverse events.
Acetaminophen: Drug Safety Communication - Association with Risk of Serious Skin Reactions08/01/2013 Medical RecallEvents are rare but can be fatal.
DePuy Orthopaedics-LPS Lower Extremity Dovetail Intercalary Component: Class 1 Recall - Potential for Fracture of Device08/01/2013 Medical RecallPatients weighing more than 200 pounds and/or those with high levels of activity are at higher risk.
Beacon Hill Medical Pharmacy/Rxtra Solutions: Recall - Lack of Sterility Assurance08/01/2013 Medical RecallSterile compounded products distributed nationwide
Nova Max Glucose Test Strips: Recall - May Report False, Abnormally High Blood Glucose Result07/29/2013 Medical RecallA false test result may lead to an insulin dosing error that could lead to a serious health risk requiring immediate medical attention.
Mefloquine Hydrochloride: Drug Safety Communication - Label Changes Due To Risk of Serious Psychiatric and Nerve Side Effects07/29/2013 Medical RecallEffects from use may include dizziness, loss of balance, ringing in the ears, feeling anxious, mistrustful, or depressed, or having hallucinations.
GE Healthcare Nuclear Medicine Systems: Class I Recall - Serious Injuries or Deaths Could Occur07/29/2013 Medical RecallFacilities are instructed to cease use of their Nuclear Medicine system until a GE Engineer is able to do a complete inspection of the system
Nizoral (ketoconazole): Drug Safety Communication - Potentially Fatal Liver Injury, Risk of Drug Interactions and Adrenal Gland Problems07/26/2013 Medical RecallNizoral tablets should be used only for the treatment of certain life-threatening mycoses when the potential benefits outweigh the risks, and alternative therapeutic options are not available or tolerated.
Healthy Life Chemistry By Purity First B-50: FDA Health Risk Warning - Undeclared Ingredients07/26/2013 Medical RecallUsing anabolic steroid-containing products may cause acute liver injury and some of the cases reported have resulted in hospitalization.
LeMaitre Vascular, Inc., Albograft Vascular Graft: Class I Recall - Blood Leak07/24/2013 Medical RecallUse of this product may cause serious adverse health consequences, including death.
Diabetes Treatments: FDA Alerts of Illegal Sales - Undeclared Ingredients07/23/2013 Medical RecallSome products may cause harm because they contain undeclared active drug ingredients or may not have been manufactured and handled according to FDA quality standards. MedStream Programmable Infusion Pump: Class 1 Recall - Malfunction In The Fill Level Sensor07/23/2013 Medical RecallThe recommended pump refill date, computed by the Control Unit, may be incorrect.
Esbelin Silouttte Te and Esbelin Siloutte Vitamin Supplement: Recall - Undeclared Drug Ingredients07/23/2013 Medical RecallThese products pose a health threat to Consumers because Sibutramine is known to increase blood pressure and/or pulse rate and other related health risks.
Bryan Medical Tracoe Mini 3.0mm Tracheostomy Tube: Class 1 Recall - Mislabeled Packaging07/22/2013 Medical RecallUsing an oversized tracheostomy tube may cause permanent injury to the trachea.
Volcano Male Enhancement Liquid and Volcano Male Enhancement Capsules: Recall - Undeclared Drug Ingredients07/22/2013 Medical RecallLab tests revealed products contain PDE 5 inhibitors and other drug ingredients that can be life threatening.
Silver Sword and Clalis by hardmenstore.com: Recall - Undeclared Drug Ingredient07/15/2013 Medical RecallUse of these products, which contain Sildenafil, can result in decreased blood pressure, light-headedness, and dizziness.
Medtronic MiniMed Paradigm Insulin Infusion Sets: Class 1 Recall - Potential for Over or Under Delivery of Insulin07/12/2013 Medical RecallMay result in hypoglycemia or hyperglycemia, which can be severe and lead to serious illness.
Verathon, Inc., GlideScope Video Laryngoscope (GVL) 3, 4, 5 and GlideScope (AVL) 2, 3, 4 and 5 Reusable Blades: Class I Recall - Risk of Blade Tip Breakage and Premature Failure07/10/2013 Medical RecallBlade may break off in patients’ mouth, where it may be swallowed or block the airway. This can lead to serious adverse health consequences, including hypoxemia (low blood oxygen), severe cuts to the airway leading to a significant loss of blood, and/or death.
Estarylla (norgestimate and ethinyl estradiol): Recall - Report of Placebo Tablet Present in Row of Active Tablets07/05/2013 Medical RecallRisk of pregnancy.
Olmesartan Medoxomil: Drug Safety Communication - Label Changes To Include Intestinal Problems (Sprue-Like Enteropathy)07/03/2013 Medical RecallEnteropathy may develop months to years after starting olmesartan, and sometimes requires hospitalization.
RECOMBIVAX HB (Hepatitis B Vaccine (Recombinant)) Adult Formulation by Merck Sharp and Dohme Corp.: Recall - Potential For Cracked Vials07/03/2013 Medical RecallIf vial is cracked, integrity of the vial and sterility of any product remaining could not be assured.
Benztropine Mesylate Injection by Fresenius Kabi USA: Recall - Potential Presence Of Glass Particles07/02/2013 Medical RecallIf present, the administration of glass particulate poses a potential safety risk to patients.
Medtronic SynchroMed Implantable Infusion System Devices: Class 1 Recalls - Feed Through Failure, Failure of Priming Bolus, and Catheter Occlusion06/28/2013 Medical RecallMedtronic SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps and Sutureless Connector Intrathecal Catheter Products Recalled.
JaDera and Xiyouji Qingzhi Dietary Supplements by Dolphin Intertrade Corp.: Recall - Undeclared Drug Ingredient06/28/2013 Medical RecallProducts have been found to contain undeclared Sibutramine, known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
Hydroxyethyl Starch Solutions: FDA Safety Communication - Boxed Warning on Increased Mortality and Severe Renal Injury and Risk of Bleeding06/24/2013 Medical RecallFDA has analyzed recent data indicating increased mortality and renal injury in critically ill adult patients who are treated with HES solutions. Posted 06/24/2013
Oxyphen, Phentalene, Phen FX, and Red Vipers by Beta Labs, LTD: Recall - Contains DMAA06/24/2013 Medical RecallIngestion of DMAA can elevate blood pressure and lead to cardiovascular problems.
Medtronic Xomed NIM Trivantage EMG Endotracheal Tube: Class I Recall - Cuff Leak or Cuff Deflation When Inflation Valve Cap Inappropriately Removed06/21/2013 Medical RecallPhysician may need to re-inflate or replace deflated tube to ensure the continued breathing support of the patient.
Respironics California, Inc. - Class 1 Recall: V60 Ventilators - Issue with software06/20/2013 Medical RecallVentilator support may be lost with potentially no audible alarm from the ventilator.
Enteric Coated Aspirin 81 mg Tablets by Advance Pharmaceutical Inc.: Recall of One Lot - May Contain Acetaminophen 500 mg Tablets06/19/2013 Medical RecallConsumers may inadvertently take Acetaminophen 500 mg instead of Enteric Coated Aspirin 81 mg which may cause severe liver damage.
Zyprexa Relprevv (Olanzapine Pamoate): Drug Safety Communication - FDA Investigating Two Deaths Following Injection06/18/2013 Medical RecallTwo patients died 3-4 days after receiving an appropriate dose of the drug. Posted 06/18/2013 Endologix, Inc. AFX Introducer System: Class 1 Recall - Reports Of Dilator Breaking During Procedures06/18/2013 Medical RecallUse of this recalled product may cause serious adverse health consequences, including death. Posted 06/18/2013
Cybersecurity for Medical Devices and Hospital Networks: FDA Safety Communication06/17/2013 Medical RecallMany medical devices contain configurable embedded computer systems that can be vulnerable to cybersecurity breaches.
May 201306/13/2013 Medical RecallMedWatch May 2013 drug safety labeling changes
Main Street Family Pharmacy in Tennessee: FDA Alerts Health Care Providers of Adverse Reactions Associated with Steroid Injections06/13/2013 Medical RecallUPDATED 06/13/2013. FDA identified the specific bacterial and fungal growth in two MPA lots. Originally posted 05/24/2013.
Warfarin 2 mg Tablets by Zydus Pharmaceuticals USA Inc.: Recall - Due to Oversized Tablets06/12/2013 Medical RecallIngestion of a greater than intended dose of Warfarin, could lead to an increased pharmacological effect of warfarin. As a result, patients would be more likely to develop bleeding and in some patients that bleeding into a critical organ could be fatal.
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