Drug and Medical Device Recalls

ICU Medical, Inc. Issues a Voluntary Nationwide Recall of Lactated Ringer's Injection, USP and 0.9% Sodium Chloride Injection, USP Due to Presence of Particulate Matter

10/30/2019 Medical Recall

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.

Ethicon Recalls ECHELON FLEX™ ENDOPATH® Staplers for Failure to Completely Form Staples

10/29/2019 Medical Recall

Some ECHELON FLEX ENDOPATH staplers may contain an out of specification component, which may cause malformed staples, which may cause patient injury or death.

Update on Risk of Type III Endoleaks with Use of Endologix AFX Endovascular AAA Graft Systems: FDA Safety Communication

10/28/2019 Medical Recall

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 Initiates Voluntary Nationwide Recall of One Lot of Alprazolam Tablets, USP C-IV 0.5 mg, Due to the Potential of Foreign Substance

10/26/2019 Medical Recall

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

Novitium Pharma Issues Voluntary National Recall of Ranitidine Hydrochloride Capsules 150mg and 300mg Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA)

10/25/2019 Medical Recall

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 Issues Voluntary Nationwide Recall of Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/ml due to an Elevated Level of the Unexpected Impurity, N-Nitrosodimethylamine (NDMA)

10/25/2019 Medical Recall

Lannett Company, Inc. today announced that it is voluntarily recalling all lots within expiry of Ranitidine Syrup

Perrigo Company plc Issues Voluntary Worldwide Recall of Ranitidine Due to Possible Presence of Impurity, N-nitrosodimethylamine (NDMA) Impurity in the Product

10/23/2019 Medical Recall

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).

Dr. Reddy’s Confirms its Voluntary Nationwide Recall of All Ranitidine Products in the U.S. Market

10/23/2019 Medical Recall

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

Sanofi Provides Update on Precautionary Voluntary Recall of Zantac OTC in U.S.

10/23/2019 Medical Recall

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®.

GL Holdings Issues Voluntary Worldwide Recall of Green Lumber Products Due to Presence of Undeclared Tadalafil

10/22/2019 Medical Recall

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

10/16/2019 Medical Recall

2019 Biologics Recalls

Date Notification	Brand Name	Product Description Important Drug Information - Humate-P [Antihemophilic Factor/von Willebrand Factor Complex (Human)] 10/16/2019 Medical Recall CSL 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 Assurance 10/15/2019 Medical Recall Viatrexx 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 Assurance 10/10/2019 Medical Recall Innoveix 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 Recalls 10/08/2019 Medical Recall The list below contains recalls that were issued in 2019. ICU Medical Issues a Voluntary Nationwide Recall of Certain Lots of Plum and Sapphire Microbore Infusion Sets with Inline Filters 10/08/2019 Medical Recall ICU 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 Medtronic Recalls 6 French Sherpa NX Active Guide Catheters Due to Separation and Fragmentation Issue 10/08/2019 Medical Recall Medtronic 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. Lung Injury Update: FDA Warns Public to Stop Using Tetrahydrocannabinol (THC)-Containing Vaping Products and Any Vaping Products Obtained Off the Street 10/04/2019 Medical Recall FDA 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. CBER FY 2019 Recall Postings 10/02/2019 Medical Recall Listing of CBER FY 2019 Recall Postings CBER FY 2018 Recall Postings 10/02/2019 Medical Recall List of CBER FY 2018 Recall Postings. 2019 Safety Communications 10/01/2019 Medical Recall 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. URGENT/11 Cybersecurity Vulnerabilities in a Widely-Used Third-Party Software Component May Introduce Risks During Use of Certain Medical Devices: FDA Safety Communication 10/01/2019 Medical Recall URGENT/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 Circuit 09/17/2019 Medical Recall FDA 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 Inflammation 09/13/2019 Medical Recall FDA 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 Medicines 09/13/2019 Medical Recall FDA 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 Inflammation 09/13/2019 Medical Recall FDA 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 Medicines 09/12/2019 Medical Recall FDA 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 Illnesses 09/09/2019 Medical Recall Consumers 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 Feed 09/05/2019 Medical Recall test 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 Product 08/30/2019 Medical Recall Both 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 Disease 08/29/2019 Medical Recall FDA 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 Dose 07/26/2019 Medical Recall Drug 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 Organisms 06/19/2019 Medical Recall FDA 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 Adults 05/16/2019 Medical Recall Safety 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 Awake 04/30/2019 Medical Recall MedWatch Alert on certain prescription insomnia medicines. E-cigarette: Safety Communication - Related to Seizures Reported Following E-cigarette Use, Particularly in Youth and Young Adults 04/03/2019 Medical Recall The 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 Patients 02/25/2019 Medical Recall FDA 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 Patients 12/20/2018 Medical Recall FDA 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 Medicine 11/20/2018 Medical Recall FDA 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 Administration 11/14/2018 Medical Recall The 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 Area 08/29/2018 Medical Recall Requiring 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 Stroke 08/17/2018 Medical Recall FDA 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 Providers 08/08/2018 Medical Recall The 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 Transplant 08/03/2018 Medical Recall The 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 Infants 11/17/2015 Medical Recall Labels of all iodinated contrast media (ICM) products will include information about these cases. No changes to current prescribing, administration, or monitoring practices are recommended. Company: ICM G5 Ventilator by Hamilton: Class I Recall - Ventilation and Alarm Failure 11/14/2015 Medical Recall If 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. Category Adverse Event Endoscope Washer/Disinfectors by Custom Ultrasonics: Safety Communication - FDA Recommends Health Care Facilities Transition to Alternate Reprocessing Methods 11/13/2015 Medical Recall Identified facility violations could result in an increased risk of infection transmission. Company: Custom Ultrasonics Plavix (clopidogrel): Drug Safety Communication - Long-term Treatment Does Not Change Risk of Death 11/06/2015 Medical Recall FDA 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. Category Health Care Myocardial Protection System (MPS) Delivery Sets by Quest Medical: Recall - Intermittent Seal Failure During Use 10/29/2015 Medical Recall Seal failure could result in patient blood loss. Auvi-Q (epinephrine injection, USP): Recall - Potential Inaccurate Dosage Delivery 10/29/2015 Medical Recall If 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 Risks 10/26/2015 Medical Recall Drug labels for Comtan and Stalevo will remain unchanged. Company: Stalevo Hepatitis C Treatments Viekira Pak and Technivie: Drug Safety Communication - Risk of Serious Liver Injury 10/22/2015 Medical Recall Cases 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 Studies 10/22/2015 Medical Recall Prescribers and patients should consider separating Kayexalate dosing from other medications taken by mouth by at least 6 hours. Category Pharmacology Downing Labs, LLC Sterile Compounded Products: Recall - Lack of Sterility Assurance 10/21/2015 Medical Recall If there is a contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening. Category Health Care Provider Heater-Cooler Devices: FDA Safety Communication - Use of Devices Associated With Nontuberculous Mycobacteria Infections 10/15/2015 Medical Recall Potential for contaminated water to transmit bacteria through the air (aerosolize) through the device’s exhaust vent into the environment and to the patient. Company: Safety Communication Acetaminophen Tablets by Medline Industries: Recall - Mislabeling with Incorrect Strength 10/15/2015 Medical Recall If the product is taken at the maximum labeled dose, or with other medications containing acetaminophen, it may lead to liver toxicity or liver failure. Company: Medline Industries, Inc. Bioprosthetic Aortic Valves: FDA Notification - Reduced Leaflet Motion 10/05/2015 Medical Recall FDA 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. Category Warfarin Drug Products Intended to be Sterile by Chen Shwezin Inc., dba Park Compounding Pharmacy: FDA Statement - Lack of Sterility Assurance 10/03/2015 Medical Recall Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death. Company: Chen Shwezin Inc. PROFEMUR Neck Varus/Valgus CoCr 8 Degree, Part number PHAC 1254 by MicroPort Orthopedics: Class I Recall - Unexpected Rate of Fractures After Surgery 10/02/2015 Medical Recall Acute fracture and emergency revision surgery is a serious adverse health consequence and could lead to neurovascular damage, hematoma, hemorrhage, or death. Company: MicroPort Orthopedics Inc. Cranial Perforators With an Automatic Clutch Mechanism: Safety Communication - Failure to Disengage 09/28/2015 Medical Recall Clutch 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. Category Brain Sterile Compounded Products by US Compounding, Inc: Recall - Lack of Sterility Assurance 09/24/2015 Medical Recall If the sterility of a compounded preparation intended to be sterile is compromised, patients may be at risk. Company: US Compounding, Inc. Avycaz (ceftazidime and avibactam): Drug Safety Communication - Dose Confusion and Medication Errors 09/22/2015 Medical Recall FDA revised the labels to indicate that each vial contains Avycaz 2.5 gram, equivalent to ceftazidime 2 gram and avibactam 0.5 gram. Company: Avycaz Tramadol: Drug Safety Communication - FDA Evaluating Risks of Using in Children Aged 17 and Younger 09/21/2015 Medical Recall Ultra-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. Category Health Care Freedom Driver System by SynCardia: Class I Recall - Part May Fail Causing Device to Stop Working 09/18/2015 Medical Recall If the device stops pumping, the patient will lose consciousness almost immediately, which can lead to serious injury or death. Company: Freedom Driver Systems Ayurvedic Dietary Supplements by Shree Baidyanath: Consumer Advice Notice - Products Contain High Levels of Lead and/or Mercury 09/17/2015 Medical Recall Testing has found that these products contain high levels of lead and/or mercury, which can cause serious health problems. Category Health Care Reprocessed Flexible Bronchoscopes: FDA Safety Communication - Risk of Infection 09/17/2015 Medical Recall If scope reprocessing procedure is not followed meticulously, the flexible bronchoscope can remain contaminated, potentially resulting in infection transmission from one patient to the next. Category Adverse Event HeartMate II Left Ventricular Assist System (LVAS) by Thoratec Corporation: Urgent Medical Device Correction - Monitor the Backup Battery Expiration Date 09/16/2015 Medical Recall Certain preventable advisory alarms may result in patients deciding to attempt a System Controller exchange. Company: Thoratec Corporation Clozapine: Drug Safety Communication - FDA Modifies Monitoring for Neutropenia; Approves New Shared REMS Program 09/15/2015 Medical Recall Enhanced labeling explaining how to monitor patients for neutropenia/manage clozapine treatment. Approval of new, shared REMS. Category Schizophrenia Miracle Diet 30 and Miracle Rock 48 Capsules by The One Minute Miracle Inc.: Recall - Due to Presence of Undeclared Drug Products 09/12/2015 Medical Recall FDA analysis revealing that these dietary supplements contain undeclared drug products making them unapproved drugs. Category Food And Drug Administration Invokana and Invokamet (canagliflozin): Drug Safety Communication - New Information on Bone Fracture Risk and Decreased Bone Mineral Density 09/10/2015 Medical Recall FDA added a new Warning and Precaution and revised the Adverse Reactions section of the Invokana and Invokamet drug labels. Company: Canagliflozin Medistat RX Sterile Drug Products: Recall - Possible Contamination 09/10/2015 Medical Recall Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death. Company: Medistat RX Compounded or Repackaged Drugs Stored in Becton-Dickinson Syringes: FDA Expands Warning 09/08/2015 Medical Recall An 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. Category Morphine Puritan Bennett 980 Ventilators by Covidien: Class I Recall - Amount of Air Delivered May Be Lower Than Programmed 09/02/2015 Medical Recall A patient not receiving enough oxygen can result in possible injury or death. Company: Ventilator System Evita V500 and Babylog VN500 Ventilators by Dräger Medical: Class I Recall - Faulty Batteries 09/02/2015 Medical Recall If the ventilator shuts down, a patient may not receive necessary oxygen. This could cause patient injury or death. Category Adverse Event DPP-4 Inhibitors for Type 2 Diabetes: Drug Safety Communication - May Cause Severe Joint Pain 08/28/2015 Medical Recall New information added to the WARNINGS AND PRECAUTIONS section of the drug labeling. Category Health Care OmniPod (Pod) Insulin Management System by Insulet Corporation: Recall - Possibility of a Higher Rate of Failure 08/28/2015 Medical Recall Use may result in interruption of insulin delivery that can cause hyperglycemia, which, if left untreated, can result in diabetic ketoacidosis. Company: Insulet Corporation 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 Pump 08/27/2015 Medical Recall Over 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 Therapy 08/27/2015 Medical Recall Failure of syringe module may result in a delay or interruption of therapy and can lead to serious patient injury or death. Category Patient Hudson RCI Sheridan Sher-I-Bronch Endobroncial Tube by Teleflex Medical: Class I Recall - Connector May Crack or Separate 08/26/2015 Medical Recall The 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. Company: Teleflex Medical Refresh Lacri-Lube, Refresh P.M., FML 0.1 Percent and Blephamide 10 Percent/0.2 Percent by Allergan: Recall - Particulate Matter 08/25/2015 Medical Recall Potential adverse events may include eye pain, eye sewelling, ocular discomfort or eye irritation. Company: Allergan Picato (ingenol mebutate) Gel: Drug Safety Communication - FDA Warns of Severe Adverse Events, Requires Label Changes 08/21/2015 Medical Recall Severe 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. Company: Picato OxyTOTE Portable Oxygen Unit by Western/Scott Fetzer Company: Class I Recall - May Ignite and Burst 08/18/2015 Medical Recall Reports of internal flash fire when the OxyTOTE is mishandled or dropped. Category Health Care Prolotherapy with Phenol by Hartley Medical: Recall - Non-sterility Concerns 08/18/2015 Medical Recall Parenteral 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. Company: Hartley Medical Compounded Drugs Stored in Becton-Dickinson (BD) 3 ml and 5 ml Syringes: FDA Warning - Do Not Use 08/18/2015 Medical Recall Preliminary 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. Category Pharmacology Mammograms at Boston Diagnostic Imaging in Orlanda, Florida: FDA Safety Communication - Quality Problems 08/17/2015 Medical Recall Patients should consider having their mammograms re-evaluated at a certified facility. Company: Safety Communication Beacon Tip Angiographic Catheters by Cook Medical: Class 1 Recall - Catheter Tip May Slip or Separate 08/07/2015 Medical Recall If 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. Company: Cook Medical Implantable Left Ventricular Assist Devices (LVADs): FDA Safety Communication - Serious Adverse Events 08/05/2015 Medical Recall Increased rate of pump thrombosis, high rate of stroke, bleeding complications. Gilenya (fingolimod): Drug Safety Communication - FDA Warns About Cases of Rare Brain Infection 08/04/2015 Medical Recall Cases of PML in two patients with no prior exposure to immunosuppressant drugs. Company: MS Duodenoscope Reprocessing: FDA Safety Communication - Supplemental Measures to Enhance Reprocessing 08/04/2015 Medical Recall Hospitals and health care facilities can, in addition to meticulously following manufacturer reprocessing instructions, take additional steps to further reduce the risk of infection. Category Endoscopic Retrograde Cholangiopancreatography Hydrochlorothiazide Tablets by Unichem Pharmaceuticals (USA), Inc: Recall - Potential Presence of Foreign Tablets Contamination 08/01/2015 Medical Recall Missing a dose of Hydrochlorothiazide could result in uncontrolled blood pressure or swelling caused by excess fluid (edema). Company: Unichem Symbiq Infusion System by Hospira: FDA Safety Communication - Cybersecurity Vulnerabilities 07/31/2015 Medical Recall The 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. Company: Symbiq Infusion System 0.9 Percent Sodium Chloride Injection, USP (AUTO-C) by Baxter International: Recall - Potential For Leaking Containers, Particulate Matter and Missing Port 07/31/2015 Medical Recall Leaking 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. Company: Baxter International Inc. Brintellix (vortioxetine) and Brilinta (ticagrelor): Drug Safety Communication - Name Confusion 07/30/2015 Medical Recall FDA warns about prescribing and dispensing errors resulting from brand name confusion with antidepressant Brintellix (vortioxetine) and antiplatelet Brilinta (ticagrelor). Category Selective Serotonin Reuptake Inhibitor Adrucil (fluorouracil injection, USP) 5 g/100 mL (50 mg/mL) by Teva Parenteral Medicines: Recall - Particulate Matter 07/27/2015 Medical Recall Administration 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. Company: Teva Parenteral Medicines Gadolinium-based Contrast Agents for Magnetic Resonance Imaging (MRI): Drug Safety Communication - FDA Evaluating the Risk of Brain Deposits With Repeated Use 07/27/2015 Medical Recall Health care professionals should consider limiting GBCA use to clinical circumstances in which the additional information provided by the contrast is necessary. Company: GBCA Sterile Human and Veterinary Compounded Drugs by Moses Lake Professional Pharmacy: Recall - Lack of Sterility Assurance 07/25/2015 Medical Recall If there is contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening. Category Health Care Provider 0.9 Percent Sodium Chloride Injection, USP, 50mL and 100mL by Baxter: Recall - Particulate Matter 07/20/2015 Medical Recall Injecting 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. Company: Baxter International Inc. Proglycem (diazoxide): Drug Safety Communication - Reports of Pulmonary Hypertension in Infants and Newborns 07/16/2015 Medical Recall Monitor patients, especially those with risk factors for pulmonary hypertension, for signs of respiratory distress, including tachypnea, flaring nostrils, grunting, and chest wall retractions. Company: Proglycem Calcium Chloride Intravenous Infusion 10% w/v 10mL Prefilled Syringe by Mylan: Market Withdrawal - Difficulties in Administration 07/14/2015 Medical Recall Calcium Chloride Intravenous Infusion 10% w/v 10mL Prefilled Syringe by Mylan: Market Withdrawal - Difficulties in Administration Company: Mylan Institutional Lariat Suture Delivery Device for Left Atrial Appendage (LAA) Closure by SentreHEART: FDA Safety Communication - Reports of Patient Deaths and Other Serious Adverse Events 07/13/2015 Medical Recall Safety and effectiveness of the Lariat Suture Delivery Device to close the LAA and prevent stroke in patients with atrial fibrillation has not been established. Category Heart Non-aspirin Nonsteroidal Anti-inflammatory Drugs (NSAIDs): Drug Safety Communication - FDA Strengthens Warning of Increased Chance of Heart Attack or Stroke 07/09/2015 Medical Recall Patients and health care professionals should remain alert for heart-related side effects the entire time that NSAIDs are being taken. Category Non Steroidal Anti Inflammatory Drug Lifesaver Single Patient Use Manual Resuscitator by Teleflex Hudson RCI: Class I Recall - Intake Port Blockage 07/02/2015 Medical Recall Recalled device may not deliver breathing support to the patient. A delay in treatment may potentially lead to patient injury or death. Company: Teleflex Unapproved Prescription Ear Drop (Otic) Products: Not FDA Evaluated for Safety, Effectiveness and Quality 07/01/2015 Medical Recall Unapproved 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. Category Health Care Provider Codeine Cough-and-Cold Medicines in Children: Drug Safety Communication - FDA Evaluating Potential Risk of Serious Side Effects 07/01/2015 Medical Recall FDA 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. Category Health Care FLOW-i Anesthesia Systems by Maquet: Class 1 Recall - Dislodged Patient Cassette May 07/01/2015 Medical Recall May cause anesthesia gas to leak and could prevent the ventilator from providing breathing support if not corrected immediately. Company: Maquet Service Daytrana Patch (methylphenidate transdermal system): Drug Safety Communication - Permanent Skin Color Changes 06/24/2015 Medical Recall New warning added to drug label to describe risk of chemical leukoderma. chemical leukoderma, have been associated with the use of the Daytrana patch. Category Attention Deficit Hyperactivity Disorder Covidien Shiley Neonatal and Pediatric Tracheostomy Tubes by Medtronic: Recall - Tubes Formed With Wider-angle Bend Than Standard Models 06/24/2015 Medical Recall Reports of 12 serious patient injuries, including breathing difficulties that impacted oxygen levels in patients. Company: Medtronic HeartWare Ventricular Assist System: Class I Recall – Updated with Multiple Reasons for Recall 06/22/2015 Medical Recall FDA will update recall with new information as it becomes available. Company: HVAD M/L Taper with Kinectiv Technology Prosthesis by Zimmer: Class I Recall - Higher than Expected Levels of Manufacturing Residues 06/20/2015 Medical Recall Can cause serious adverse health issues including allergic reactions, pain, infections, or death. Company: Zimmer HeartWare Ventricular Assist System: Class I Recall - Damaged Alignment Guides or Connection Pins May Cause Pump to Stop 06/16/2015 Medical Recall An interruption in electrical connection would cause the pump to stop, which could cause serious patient injury or death. Company: HeartWare Potiga (ezogabine): Drug Safety Communication - FDA Determines 2013 Labeling Adequate to Manage Risks of Retinal Abnormalities, Potential Vision Loss, and Skin Discoloration 06/16/2015 Medical Recall Health 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. Company: Potiga Vascu-Guard Peripheral Vascular Patch by Baxter: Recall - Difficulty Distinguishing the Smooth from Rough Surface 06/03/2015 Medical Recall Incorrect 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 Company: Baxter International Inc. Unintentional Injection of Soft Tissue Filler into Blood Vessels in the Face: FDA Safety Communication - Risk of Serious Patient Injury 05/28/2015 Medical Recall Risk of embolization, which can cause vision impairment, blindness, stroke and damage and/or death of the skin and underlying facial structures. Category Health Care Provider Avea Ventilator by CareFusion: Recall - Potential Malfunction of Pressure Transducer 05/27/2015 Medical Recall Ventilator may activate false Extended High Ppeak or Circuit Occlusion audio and visual alarms, open the safety valve and stop ventilating. Company: CareFusion Zerbaxa (ceftolozane and tazobactam): Drug Safety Communication - FDA Cautions about Dose Confusion and Medication Errors 05/20/2015 Medical Recall Can lead to to administration of more drug than was prescribed. Company: Zerbaxa SGLT2 inhibitors: Drug Safety Communication - FDA Warns Medicines May Result in a Serious Condition of Too Much Acid in the Blood 05/15/2015 Medical Recall High levels of blood acids called ketones may require hospitalization. Posted 05/15/2015 Category Medical Prescription LifeCare PCA3 and PCA5 Infusion Pump Systems by Hospira: FDA Safety Communication - Security Vulnerabilities 05/13/2015 Medical Recall An 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. Company: Infusion Pump Systems Tiger Paw System II by Maquet Medical Systems: Class I Recall - May Cause Tears and Bleeding in Heart Tissue 05/07/2015 Medical Recall Possibility of a tear on the left atrial wall during use of the device. Company: Maquet Medical Systems Adrucil (fluorouracil Injection, USP) 5 g/100 mL (50 mg/mL): Recall - Particulate Matter 05/05/2015 Medical Recall Administration 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. Company: Teva Parenteral Medicines Mammograms at Coastal Diagnostic Center in Pismo Beach, California: FDA Safety Communication - Quality Problems 04/30/2015 Medical Recall Patients may need a repeat mammogram or additional medical follow-up. Company: Safety Communication Injectable Products by Mylan: Recall - Presence of Particulate Matter 04/24/2015 Medical Recall Administration of a sterile injectable that has foreign particulates has the potential of severe health consequences. Company: Agila Onco Therapies Limited Bupivacaine HCl Injection by Hospira: Recall - Iron Oxide Particulate In Glass Vials 04/24/2015 Medical Recall Injected particulate may result in local inflammation, low-level allergic or immune responses, granuloma formation or mechanical irritation of tissue. Company: Hospira Ebola Virus One-Step Test Kits by LuSys Laboratories: Class I Recall - Not Cleared for Marketing 04/23/2015 Medical Recall The 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 Company: LuSys Laboratories Mucinex Fast-MAX Products: Recall - Incorrect Labeling 04/22/2015 Medical Recall Consumers could take a product with undeclared levels of acetaminophen, dextromethorphan, guaifenesin, phenylephrine and/or diphenhydramine. Company: Reckitt Benckiser Flurbiprofen-Containing Topical Pain Medications: FDA Alert - Illnesses and Deaths in Pets Exposed to Prescription Topical Pain Medication 04/17/2015 Medical Recall Evidence of NSAID toxicity in the pets exposed to flurbiprofen and died. Category Non Steroidal Anti Inflammatory Drug VV13F Reinforced Dual Lumen ECMO Catheters by OriGen Biomedical: Recall - Potential for Separation of Tube from Hub 04/16/2015 Medical Recall Separation could result in required intervention to prevent permanent impairment or damage. Company: OriGen Biomedical Intravenous (IV) Solutions (Select Lots) by Baxter: Recall - Potential Presence of Particulate Matter 04/10/2015 Medical Recall Particles in IV solutions may cause: local vein irritation, inflammatory reaction, aggravation of preexisting infections, allergic reactions, and systemic embolization. Company: Baxter International Inc. Products from Prescription Center Pharmacy in Fayetteville, N.C.: Recall - Lack of Sterility Assurance 04/02/2015 Medical Recall Human and veterinary drug products made by the Prescription Center have been distributed nationwide and to Canada. Company: Prescription Center Feraheme (ferumoxytol): Drug Safety Communication – Warnings Strengthened and Prescribing Instructions Changed 03/31/2015 Medical Recall Risk of potentially life-threatening allergic reactions. Company: Feraheme Duodenoscope Model TJF-Q180V by Olympus: FDA Safety Communication - New Reprocessing Instructions Validated 03/26/2015 Medical Recall If not properly reprocessed patients may be exposed to serious infections. Company: Olympus Mammograms at Richard D. Adelman M.D. in Raleigh, North Carolina: FDA Safety Communication - Quality Problems 03/24/2015 Medical Recall The facility may not perform mammography due to the revocation of its accreditation. Category Mammography Quality Standards Act 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 Amiodarone 03/24/2015 Medical Recall Postmarketing cases of serious and life-threatening symptomatic bradycardia, as well as one fatal cardiac arrest and cases requiring pacemaker insertion, have been reported. Category Amiodarone Zyprexa Relprevv (olanzapine pamoate): Drug Safety Communication - FDA Review of Study Sheds Light on Two Deaths Associated with the Injectable Schizophrenia Drug 03/23/2015 Medical Recall FDA 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. Company: Zyprexa Relprevv Over-the-Counter Asthma Products Labeled as Homeopathic: FDA Statement - Consumer Warning About Potential Health Risks 03/19/2015 Medical Recall If asthma is not appropriately treated and managed, patients may be at risk for life-threatening asthma attacks. Category Asthma Lactated Ringer's Irrigation, 3000mL by Hospira: Recall - Mold Contamination 03/12/2015 Medical Recall Contaminated solution used on a patient may result in bacteremia, sepsis, septic shock and endocarditis, and death may result. Company: Hospira Treanda (bendamustine hydrochloride) Solution by Teva: FDA Statement - Not Compatible with Closed System Transfer Devices, Adapters, and Syringes Containing Polycarbonate or Acrylonitrile-Butadiene-Styrene 03/11/2015 Medical Recall Can lead to device failure, possible product contamination, and potential serious adverse health consequences. Company: Treanda Injection Chantix (varenicline): Drug Safety Communication - FDA Updates Label to Include Potential Alcohol Interaction 03/09/2015 Medical Recall Rare risk of seizures, and studies of side effects on mood, behavior, or thinking. Posted 03/09/2015 Category Smoking Cessation Magnesium Sulfate in 5 Percent Dextrose Injection by Hospira: Recall - Incorrect Barcode Labeling 03/06/2015 Medical Recall Potential 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. Company: USP Plum A+ and Plum A+3 Infusion Systems by Hospira: Class I Recall - Alarm Volume Failure 03/06/2015 Medical Recall Risk of injury or death resulting from prolonged interruption in therapy. Company: Stericycle, Inc. 0.9 Percent Sodium Chloride Injection, USP, 250 mL VisIV Container by Hospira: Recall - Particulate Matter 03/06/2015 Medical Recall Injected particulate material may result in localized inflammation, phlebitis, allergic reaction, granuloma formation or microembolic effects, and/or low-level allergic response. Company: Hospira 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 Stroke 03/03/2015 Medical Recall FDA 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. Company: Testosterone Products HeartWare Ventricular Assist System Controllers by HeartWare International: Recall - Clinical Trial Controllers Susceptible to Electrostatic Discharge 02/27/2015 Medical Recall Electrostatic 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 Assurance 02/25/2015 Medical Recall Administration 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. Company: Heritage Pharmaceuticals Inc. Magnetic Resonance Imaging (MRI) Systems with Magnet Rundown Unit by GE Healthcare: Class I Recall - Potential Disabling of the Magnet Rundown Unit 02/25/2015 Medical Recall Risk of life-threatening injuries or death if a metal object is brought into the magnetic field. Company: GE Healthcare MAQUET Servo Humidifier 163 by Teleflex Medical: Class I Recall - Cracks in Connector Tubes May Lead to Leak Failures 02/25/2015 Medical Recall Cracks may prevent device from delivering sufficient support to the patient. This may potentially cause serious injury or death. Company: INMED Atracurium Besylate Injection by Sagent Pharmaceuticals: Recall - Potential Impact on Product Sterility 02/24/2015 Medical Recall Has the potential to result in infections, which could be fatal, especially in patients who are immunocompromised. Company: Atracurium Besylate Injection Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes: FDA Safety Communication - Design May Impede Effective Cleaning 02/19/2015 Medical Recall Patients may be exposed to serious infections. Category Health Care Ketorolac Tromethamine Injection by Hospira: Recall - Particulate in Glass Vials 02/11/2015 Medical Recall Administration of particulates has the potential for localized inflammation, allergic reaction, granuloma formation, microembolic effects, or delay of therapy. Company: Hospira Trellis 6 and Trellis 8 Peripheral Infusion Systems by Covidien: Class I Recall - Balloon Inflation Ports Mislabeled 02/11/2015 Medical Recall The 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. Company: Covidien 0.9 Percent Sodium Chloride Injection, USP, 250 mL by Hospira : Recall - Particulate Matter 01/23/2015 Medical Recall Injected particulate material may result in local inflammation, phlebitis, and/or low-level allergic response. Company: Hospira Bone Graft Substitutes Containing Recombinant Proteins or Synthetic Peptides in Patients Under Age 18: FDA Safety Communication - Reports of Serious Injuries 01/21/2015 Medical Recall Risk of excess bone growth, fluid accumulation, inhibited bone healing, and swelling. Category Health Care Provider Simulated IV Solutions from Wallcur: CDER Statement- FDA's Investigation into Patients being Injected 01/14/2015 Medical Recall Adverse events include fever, chills, tremors and headache,and there is one death associated with the use of these products. Company: Wallcur Prescription and Over-the-Counter (OTC) Pain Medicines: Drug Safety Communication - FDA Review of Possible Risks of Pain Medicine Use During Pregnancy 01/09/2015 Medical Recall Pregnant women urged to discuss all medicines with their health care professionals before using them. Category Non Steroidal Anti Inflammatory Drug Virazole (Ribavirin Powder For Solution) by Valeant Pharmaceutical North America, LLC: Recall- Due to Microbial Contamination 01/02/2015 Medical Recall Inhalation of a non-sterile product with microbial contamination into the airways could increase the risk of respiratory infection. Company: Valeant Pharmaceutical North America KimVent Microcuff Subglottic Suctioning Endotracheal Tubes by Halyard Health: Class I Recall - Component May Detach During Use 12/31/2014 Medical Recall An 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. Company: Halyard Health Nellcor Puritan Bennett 980 Ventilator System by Covidien: Class I Recall - Component Failure May Cause Burning Odor 12/31/2014 Medical Recall Problems in the manufacturing process may lead to unexpected need to stop the ventilator and transfer the patient to another ventilator. Company: Covidien IV Solutions from Wallcur of San Diego: CDER Statement - FDA Warns Health Care Professionals Not to Inject Patients 12/31/2014 Medical Recall There have been reports of serious adverse events associated with the use of certain of these products. Company: Wallcur Caramel Apples: Warning - Illnesses, Including Deaths, Linked to Listeria Monocytogenes Contamination 12/26/2014 Medical Recall Listeriosis 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). Company: Apple Mitoxantrone by Hospira: Recall - Confirmed Subpotency and Out-Of-Specification 12/24/2014 Medical Recall Potential for decreased potency which can lead to decreased effectiveness, additional dosing, and the potential for cumulative impurity toxicity requiring medical intervention. Company: Hospira SLIM-K Capsules by Bethel Nutritional Consulting, Inc.: Recall - Undeclared Drug Ingredients 12/22/2014 Medical Recall Can 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. Company: Bethel Nutritional Consulting, Inc. B-Lipo Capsules by Bethel Nutritional Consulting, Inc.: Recall - Undeclared Drug Ingredient 12/22/2014 Medical Recall Serious 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. Company: Bethel Nutritional Consulting, Inc. 0.9 Percent Sodium Chloride Injection USP in 100 mL MINI-BAG PLUS Container by Baxter: Recall - Particulate Matter 12/16/2014 Medical Recall Intravenous administration of a solution containing particulate matter may lead to local vein irritation, inflammatory reaction, aggravation of preexisting infections, allergic reactions, and systemic embolization. Company: Baxter International Inc. Ziprasidone (Marketed as Geodon and Generics): Drug Safety Communication - Rare But Potentially Fatal Skin Reactions 12/11/2014 Medical Recall Symptoms 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. Category Atypical Antipsychotic Dietary Supplements Containing Live Bacteria or Yeast in Immunocompromised Persons: Warning - Risk of Invasive Fungal Disease 12/09/2014 Medical Recall FDA advises practitioners to approach the application of these interventions with caution. Company: ABC Dophilus Powder Heart Sync Inc. Multi-function Defibrillation Electrodes: Device Correction - Connector Incompatibility with Philips FR3 and FRx Defibrillator Units 12/03/2014 Medical Recall May result in a delay in therapy. Company: Heart Sync Inc. Siemens Healthcare Diagnostics, Rapid Gram Negative Combo Panels: Class I Recall - May Produce Incorrect Results 12/02/2014 Medical Recall Using these recalled devices may cause ineffective patient treatment. Category Pseudomonas Aeruginosa CONMED PadPro and R2 Multi-function Defibrillation Electrodes: Device Correction - Connector Compatibility Issue With Philips FR3 and FRx Defibrillator Units 11/26/2014 Medical Recall May result in a delay in therapy. Company: Philips Slim-Vie: Public Notification - Undeclared Drug Ingredient 11/26/2014 Medical Recall Sibutramine 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. Category Medicine Tecfidera (dimethyl fumarate) by Biogen Idec: Drug Safety Communication - Case of Rare Brain Infection PML Reported 11/25/2014 Medical Recall Symptoms 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. Company: Tecfidera Super Extreme Accelerator: Public Notification - Undeclared Drug Ingredient 11/24/2014 Medical Recall Sibutramine 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. Category Medicine Bee Thin: Public Notification - Undeclared Drug Ingredient 11/24/2014 Medical Recall Sibutramine 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. Category Medicine Black Storm: Public Notification - Undeclared Drug Ingredient 11/24/2014 Medical Recall Sildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Category Erectile Dysfunction Bee Slim: Public Notification - Undeclared Drug Ingredient 11/24/2014 Medical Recall Sibutramine 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. Category Medicine Gabapentin Capsules, USP 300 mg, by Aurobindo Pharma USA: Recall - Complaints of Empty Capsules 11/24/2014 Medical Recall Risk 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. Company: Aurobindo Pharma USA Highly Concentrated Potassium Chloride Injection, 10 mEq per 100 mL by Baxter: Recall - Mislabeled Overpouch 11/21/2014 Medical Recall Administration of a dose lower than intended, especially in patients prone to severe electrolyte imbalance, may lead to serious, life-threatening adverse health consequences. Company: Baxter International Inc. Forever Beautiful Bee Pollen by REFA Enterprises: Recall - Undeclared Drug Ingredients 11/20/2014 Medical Recall Risk for those with a history of coronary artery disease, congestive heart failure, arrhymias or stroke Company: REFA Enterprises Respironics California, Esprit V1000 and V200 Ventilators: Class I Recall - Power Failure May Occur 11/19/2014 Medical Recall Failure 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. Company: Generation Power Supplies ABC Dophilus Powder by Solgar, Inc: Recall - Risk of Infection 11/17/2014 Medical Recall The 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. Company: Solgar ABC Dophilus Powder Long-term Antiplatelet Therapy: Safety Announcement - Preliminary Trial Data Shows Benefits But a Higher Risk of Non-Cardiovascular Death 11/16/2014 Medical Recall FDA believes the benefits of clopidogrel (Plavix) and prasugrel (Effient) therapy continue to outweigh their potential risks when used for approved uses. Category Myocardial Infarction Gel-E Donut and Squishon 2 Products by Children’s Medical Ventures: Recall - Potential Mold Contamination 11/15/2014 Medical Recall There is the possibility of fungal infection should patients come in contact with the mold. Company: Philips Healthcare Mayhem: Public Notification - Undeclared Drug Ingredients 11/14/2014 Medical Recall Risk of impaired ability to fight infections, high blood sugar levels, muscle injuries, and psychiatric problems. Category Health Care Nellcor Puritan Bennett, 980 Ventilator System: Class I Recall - Software Issue May Stop Ventilator 11/07/2014 Medical Recall Ventilator 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. Company: Covidien GemStar Power Supply, 3VDC for GemStar Infusion Pumps by Hospira: Class I Recall - Power Supply May Not Deliver Enough Electricity 11/05/2014 Medical Recall Use 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. Company: GemStar Infusion Pump V26 Slimming Coffee: Public Notification - Undeclared Drug Ingredient 11/05/2014 Medical Recall Sibutramine 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. Category Medicine 10 Percent Neutral Buffered Formalin by Richard-Allan Scientific: Class I Recall - May Contain Incorrect Concentration of Formalin 10/31/2014 Medical Recall Use of this defective Formalin may prevent or delay diagnoses and treatment decisions. Company: Emergency Medicine Ginseng Kianpi Pil: Public Notification - Undeclared Drug Ingredients 10/31/2014 Medical Recall Risk 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. Company: Kweilin Drug Manufactory Baby Wipes by Nutek Disposables, Inc.: Recall - May Contain Bacteria 10/27/2014 Medical Recall Those with weakened immune system or chronic lung disease may be more susceptible to infections with B. cepacia. Company: Nutek Intravia Containers by Baxter: Recall - Particulate Matter 10/25/2014 Medical Recall Intravenous administration of a solution containing sterile particulate matter may lead to adverse health consequences. Posted 10/25/2014 Company: INTRAVIA Container Assured Brand Naproxen Sodium Tablets by Contract Packaging Resources, Inc.: Recall - Packaging Mix-Up 10/22/2014 Medical Recall Risk of allergic reactions, from mild irritation or hives to serious reactions such as anaphylaxis that may be life-threatening. Company: Dollar Tree Saba Shark Cartilage Complex, 60 Capsule Bottles: Recall - Possible Salmonella Contamination 10/20/2014 Medical Recall Salmonella can cause serious and sometimes fatal infections in young children frail or elderly people, and others with weakened immune systems. Posted 10/20/2014 Company: AMS Health Sciences Lidocaine HCI Injection, USP 10 MG Per ML, 30 ML Single-Dose, Preservative-Free, by Hospira: Recall - Particulate Matter 10/17/2014 Medical Recall Injected particulate material may result in local inflammation, phlebitis, and/or low-level allergic response to the particulate or microembolic effects. Company: Hospira September 2014 10/16/2014 Medical Recall September 2014 Drug Safety Labeling Changes includes 55 products with revisions to Prescribing Information. Category 5 Ht3 Antagonist LifeCare Flexible Intravenous Solutions by Hospira, Inc.: Recall - Potential for Leakage 10/15/2014 Medical Recall A puncture in the primary container may be difficult to detect and lead to contamination, compromised sterility, and other adverse events. Company: Stericycle Medi-Trace Cadence and Kendall Multi-function Defibrillation Electrodes by Covidien: Field Safety Alert - Electrodes Will Not Connect with Philips FR3 or FRx AED units 10/13/2014 Medical Recall The mismatch of these devices could contribute to a delay in resuscitation and may contribute to subsequent death. Company: Philips Sit and Slim II: Public Notification - Hidden Drug Ingredients 10/10/2014 Medical Recall FDA 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. Category Hypertension ICU Medical ConMed Stat2 Flow Controller: Class 1 Recall - Delivers Higher Flow Rate than Intended 10/10/2014 Medical Recall Use of the affected product may cause serious adverse health consequences, including death. Company: ICU Medical, Inc CareFusion EnVe and ReVel Ventilators: Class 1 Recall - Power Connection Failure 10/10/2014 Medical Recall Ventilator shut-off from power failures may lead to serious patient injury or death. Company: CareFusion Oregon Compounding Centers, Inc. Unexpired Sterile Products: Recall - Lack of Sterility Assurance 10/10/2014 Medical Recall Patients in Oregon and Washington may be at risk of serious infections which may be life threatening. Company: Oregon Compounding Centers Vancomycin Hydrochloride for Injection USP, Equivalent to 1 Gram Vancomycin (Sterile Powder) by Hospira, Inc.: Recall - Uncontrolled Storage During Transit 10/08/2014 Medical Recall One lot may have experienced temperature excursions during shipment. Company: Stericycle SAM Junctional Tourniquet Accessory (Axilla) Strap - SAM Medical Products: Recall - Potential Clip Failure 10/08/2014 Medical Recall Product failure could cause a potential delay in controlling axilla hemorrhage. Company: SAM Medical Products Hudson RCI Pediatric Anesthesia Breathing Circuits by Teleflex Medical: Class I Recall - Circuit Ends May Crack or Break 10/07/2014 Medical Recall Defect could cause serious health risks, including delayed patient treatment, breathing difficulties, or death if not replaced immediately. Company: Teleflex Medical Ketorolac Tromethamine Injection, USP, 30mg/ml by Sagent Pharmaceuticals: Recall - Incorrect Labeling 10/06/2014 Medical Recall The labeled expiration date is longer than the known stability of the product. Company: Ketorolac Tromethamine Injection Bo Ying Compound by Eu Yan Sang (Hong Kong) Ltd: FDA/CDER Statement - Risk of Lead Poisoning 09/27/2014 Medical Recall Exposure to lead can cause serious damage to the central nervous system, the kidneys, and the immune system. Company: Hong Kong) Ltd. Xolair (omalizumab): Drug Safety Communication - Slightly Elevated Risk of Cardiovascular and Cerebrovascular Serious Adverse Events 09/26/2014 Medical Recall FDA approves label changes after review of a five year safety study. Category Asthma Potassium Chloride Injection (Baxter): Recall - Shipping Carton Mislabeling 09/17/2014 Medical Recall Potential risk of medication error or delay in therapy for patients that require high concentration potassium chloride. Company: Baxter International Inc. 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 Matter 09/12/2014 Medical Recall Risk of injected particulate material which may result in local inflammation, phlebitis, and/or low-level allergic response. Company: Hospira Pharmacy Creations Certain Products: Recall – Potential Non-Sterility 09/06/2014 Medical Recall Compromised sterility of a product may lead to risk for infection Company: Pharmacy Creations Martin Avenue Pharmacy, Inc. Compounded Sterile Preparations: Recall - Lack of Assurance of Sterility 09/02/2014 Medical Recall Compromised sterility of a compounded preparation may lead to risk for infection. Category Health Care Dermatend Original and Dermatend Ultra: Recall - Safety Concerns 09/02/2014 Medical Recall Using these Dermatend products instead of seeking medical attention could result in delayed diagnosis of conditions such as cancer. Company: Dermatend Original DePuy Synthes Craniomaxillofacial Distraction System: Class I Recall - May Reverse Directions After Surgery 08/28/2014 Medical Recall Infants 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. Company: DePuy Synthes Sterile Convenience Surgical Packs by Customed, Inc.: Recall - Potential Loss of Sterility 08/26/2014 Medical Recall Potential adhesion defect which may lead to infection. Company: Customed, Inc. Children’s Medical Ventures Gel-E Donut and Squishon 2: Class 1 Recall - Possibility of Mold 08/22/2014 Medical Recall Cladosporium and Penicillium Fungi which may cause difficulty in breathing, allergic reactions and serious health consequences, including death. Company: s Medical Ventures CloverSnare 4-Loop Vascular Retrieval Snare by Cook Medical: Recall - Risk of Loop to Separate From Shaft 08/20/2014 Medical Recall Use 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. Company: Cook Medical Diamondback 360 Peripheral Orbital Atherectomy System by Cardiovascular Systems: Class I Recall - Sheath May Fracture During Use 08/19/2014 Medical Recall Fragments of the sheath could possibly block blood vessels. Company: Orbital Atherectomy Systems Dianeal Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with 2.5 Percent Dextrose 5000mL (Ambu-Flex II): Recall - Presence of Particulate Matter 08/15/2014 Medical Recall Particulate matter could potentially serve as a focal point for infection should any pre-existing peritonitis exist, and may lead to a fatal outcome. Company: Baxter International Inc. IPM Wound Gel by Edwards Pharmaceuticals: Class I Recall - Microbial Contamination 08/12/2014 Medical Recall Use of the affected product may cause serious adverse health consequences, including sepsis, limb loss, and death. Company: Edwards Pharmaceuticals Inc. Arize: Public Notification - Undeclared Drug Ingredient 08/11/2014 Medical Recall Undeclared sulfoaildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Company: Arize Herbal Vigor Quick Fix: Public Notification - Undeclared Drug Ingredient 08/11/2014 Medical Recall Undeclared tadalafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Category Pharmacology CUBICIN (daptomycin for injection) 500 mg in 10 mL Single Use Vials: Recall - Foreign Particulate Matter 08/09/2014 Medical Recall Administration of particulate matter poses a potential safety risk to patients such as a thromboembolism or a life-threatening pulmonary embolism. Company: Cubist Pharmaceuticals White and Blue Lion Tattoo Kits: Recall - Bacterial Contamination of Needles and Ink Bottles 08/08/2014 Medical Recall Use of these products may cause bacterial infection and can lead to sepsis, a potentially life-threatening complication of an infection. Company: Primary Care Provider RegenESlim Appetite Control Capsules: Recall - Presence Of DMAA 08/08/2014 Medical Recall DMAA 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. Company: DMAA Cubicin (daptomycin for injection) 500 mg in 10 mL Single Use Vials: Recall - Presence Of Particulate Matter 08/08/2014 Medical Recall The administration of a glass particulate poses a potential safety risk to patients such as a thromboembolism or a life-threatening pulmonary emboli. Company: Cubicin Expression Injectable by Enhancement Medical: FDA Safety Communication - Adverse Events Associated with Unapproved Use As a Dermal Filler 08/05/2014 Medical Recall Events have included swelling, tenderness, firmness, lumps, bumps, bruising, pain, redness, discoloration, itching, and the development of hard nodules. Company: Enhancement Medical LLC Lidocaine HCI Injection, USP, 2 percent, by Hospira: Recall - Visible Particulates 07/30/2014 Medical Recall Injected particulate could result in delay in therapy, local inflammation, mechanical disruption of tissue or immune response to the particulate. Company: Hospira 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 Injury 07/25/2014 Medical Recall Physicians may make decisions based on incorrect values which could lead to permanent, irreversible impairment or life-threatening changes in patients. Category Health Care Ibuprofen and Oxcarbazepine Tablets by American Health Packaging: Recall - Mislabeled Packaging 07/21/2014 Medical Recall Failure 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. Company: Oxcarbazepine Tablets Sterile Drug Products by Downing Labs (aka NuVision Pharmacy): Drug Alert - Lack of Sterility Assurance 07/19/2014 Medical Recall Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death Company: NuVision Pharmacy Baxter IV Sodium Chloride and Potassium Chloride Solutions: Recall - Particulate Matter 07/18/2014 Medical Recall If infused, the presence of particulate foreign matter may elicit inflammatory and allergic responses, both chronic and acute, and may be life threatening. Company: Potassium Chloride Solutions Sterile Drug Products by Unique Pharmaceuticals Ltd.: Alerting Health Care Professionals - Lack of Sterility Assurance 07/12/2014 Medical Recall Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death. Company: Unique Pharmaceuticals Hospira Lactated Ringer's And 5% Dextrose Injection, 1000 ML, Flexible Containers: Recall (One Lot) - Mold Contamination 07/11/2014 Medical Recall Voluntary 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. Company: Hospira Lactated Ringer Weight Loss Products: Public Notification - Undeclared Drug Ingredients 07/09/2014 Medical Recall May present significant risk for patients with history of CAD, CHF, arrhythmias, or stroke. May interact, in life-threatening ways, with other medications. Category Hypertension Langston V2 Dual Lumen Catheters (Models 5540 and 5550) by Vascular Solutions: Class I Recall - Inner Catheter May Separate During Use and Cause Injury 07/07/2014 Medical Recall The use of affected product may cause serious adverse health consequences, including death. Company: Vascular Solutions Medtronic Duet External Drainage and Monitoring System, Medtronic Neurosurgery: Class 1 Recall - Tubing May Disconnect and Lead to Injury 07/02/2014 Medical Recall Device failure may result in air within skull, infection, and over/under drainage of CSF that may contribute to serious adverse health consequences, including death. Category Intracranial Pressure Coumadin (warfarin sodium) for Injection by Bristol-Myers Squibb: Recall - Particulate Matter 07/01/2014 Medical Recall Injected particulate metallic and non-metallic cellulose material can cause serious and potentially fatal adverse reactions such as embolization. Company: Bristol-Myers Squibb Company Medical Supply Liquidators Injectable Vitamin Products With a "Sunshine Labs" Label: Warning - Products Not FDA Approved 06/30/2014 Medical Recall All lots of non-expired products being recalled. Company: Medical Supply Liquidators Lidocaine Viscous: Drug Safety Communication - Boxed Warning Required - Should Not Be Used to Treat Teething Pain 06/26/2014 Medical Recall Too much viscous lidocaine given to infants and young children can result in seizures, severe brain injury, and problems with the heart. Category Lidocaine Over-The-Counter Topical Acne Products: Drug Safety Communication - Rare But Serious Hypersensitivity Reactions 06/25/2014 Medical Recall Reactions may include throat tightness; difficulty breathing; feeling faint; or swelling of the eyes, face, lips, or tongue. Company: Neutrogena Olmesartan: Drug Safety Communication - FDA Review Finds Cardiovascular Risks for Diabetics Not Conclusive 06/24/2014 Medical Recall Recommendations for use remain the same; label updates required. Category Hypertension Red Yeast Rice by Doctor’s Best: Recall - Undeclared Lovastatin 06/24/2014 Medical Recall Use 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. Category Statin Big Sky Diagnostic Imaging, LLC in Butte, Montana: FDA Safety Communication - Mammography Problems 06/23/2014 Medical Recall Patients 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. Category Health Care Testosterone Products: FDA/CDER Statement - Risk of Venous Blood Clots 06/20/2014 Medical Recall Warning about venous thromboembolism, including deep vein thrombosis and pulmonary embolism. Category Vein ConvaTec, Inc., Flexi-Seal CONTROL Fecal Management System Kit: Class I Recall - Not Cleared for Marketing 06/20/2014 Medical Recall Reports of 12 serious injuries and one death. Company: ConvaTec, Inc. Docetaxel: Drug Safety Communication - May Cause Symptoms of Alcohol Intoxication 06/20/2014 Medical Recall Docetaxel contains alcohol, which affects the central nervous system. Category Chemotherapy HydroFinity Hydrophilic Guidewires by NDC/Covidien: Recall - Outer Jacket Damage 06/20/2014 Medical Recall Damage to the jacket can result in embolization of polymer, potentially leading to vessel occlusion or damage. Company: Covidien Weight Loss Products: Immediate Public Notification: Undeclared Drug Ingredients 06/19/2014 Medical Recall Products may substantially increase blood pressure and/or pulse rate in some patients. Category Selective Serotonin Reuptake Inhibitor Marcaine (Bupivacaine HCI Injection, USP), 0.5 percent, 30 ML, Single-Dose, Preservative-Free Vial: Recall - Visible Particulates 06/18/2014 Medical Recall Injected particulate could result in blocked administration of the drug to the patient, causing a delay in therapy. Company: Hospira May 2014 06/13/2014 Medical Recall Safety Labeling Changes includes 37 products with revisions to Prescribing Information. Posted 06/13/2014. Category File Format Captomer and Captomer-250 by Thorne Research: FDA Warning - Potential Health Risks 06/13/2014 Medical Recall FDA advises consumers to avoid all products offered over-the-counter (OTC) for chelation or detoxification. Company: Thorne Research Smiths Medical Portex Low Dead Space Connector with Sideport, 3.5mm: Class I Recall- One Lot Mislabeled 06/13/2014 Medical Recall One lot of 3.0mm sized connectors were placed in packages labeled as 3.5mm. Company: Smiths Medical Advocate Redi-Code+ Blood Glucose Test Strips by Diabetic Supply of Suncoast: Recall- Labeling Error 06/11/2014 Medical Recall Delayed or inappropriate treatment of hyperglycemic or hypoglycemic states due to missed/delayed detection could lead to serious health consequences, including death. Company: Diabetic Supply La Jiao Shou Shen: Public Notification - Undeclared Drug Ingredient 06/11/2014 Medical Recall Cancer-causing risk in addition to increased blood pressure and/or pulse rate. Category Medicine Male Sexual Enhancement Products: Immediate Public Notification: Undeclared Drug Ingredients 06/03/2014 Medical Recall Risk of interaction with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. Company: Eyeful Soliris (eculizumab) Concentrated Solution for IV Infusion by Alexion: Recall - Visible Particulates 06/02/2014 Medical Recall Particulates could cause blockage of blood flow, which could be life-threatening. Company: Alexion Advanced Sterilization Products Sterrad Cyclesure 24 Biological Indicator: FDA Safety Communication - Product Shortage 05/23/2014 Medical Recall Hospitals should prioritize use of existing supplies based on patients with the most critical need until supplies are able to meet demand. Company: Advanced Sterilization Products Fisher and Paykel Healthcare, Ltd., Infant Nasal CPAP Prongs: Class I Recall - Prongs May Detach from Nasal Tubing and Interrupt Therapy 05/23/2014 Medical Recall Device malfunction may lead to low blood oxygen (hypoxemia), and a risk of choking and airway obstruction. Company: Fisher & Paykel Healthcare NaturaLyte Liquid Bicarbonate Concentrate: Recall - Potential Health Risk 05/22/2014 Medical Recall Bacterial contamination of the dialysate may lead to bacteremia or systemic infection. Company: Fresenius Medical Care North America Baxter ABACUS TPN Calculation Software: Class I Recall - Software Errors May Cause Toxic/Overdose Symptoms 05/22/2014 Medical Recall A fatal outcome is possible, especially with the high risk population. Company: Baxter Support Services Alaris Pump Module (Model 8100), Version 9.1.18 Software by CareFusion 303, Inc: Class I Recall - May Not Properly Delay an Infusion 05/21/2014 Medical Recall "Delay Until" Option or "Multidose" feature software failure may result in unintented infusion start time. Company: Alaris Pump Ventlab Resuscitator Bags: Recall - Possible Health Risk 05/16/2014 Medical Recall May result in delay of treatment, life threatening health consequences that include hypoxia and hypoventilation. Company: Ventlab Resuscitator Bags MV5 Days: Public Notification - Undeclared Drug Ingredient 05/16/2014 Medical Recall May interact with nitrates found in some prescription drugs, and may lower blood pressure to dangerous levels. Category Erectile Dysfunction Asset Bold: Public Notification - Undeclared Drug Ingredient 05/16/2014 Medical Recall Risk of increased blood pressure and/or pulse rate. Category Heart April 2014 05/16/2014 Medical Recall Drug Safety Labeling Changes, April 2014 Category The Legend Of Zelda: A Link To The Past Labetalol Hydrochloride Injection 100 MG/20 ML (5MG/ML), 20 ML, Multidose Vial by Hospira: Recall - Visible Particulates 05/16/2014 Medical Recall Risk of injection site reactions and local irritation in the blood vessels, tissues and organs or delay in therapy. Company: Hospira, Inc. Eszopiclone Containing Sleep Aids: Drug Safety Communication - Can Cause Next-Day Impairment 05/15/2014 Medical Recall FDA recommends a decreased starting dose for both women and men. Category Food And Drug Administration Dobutamine Injection (250mg/20mL)/Hospira: Recall - Visible Particulates 05/15/2014 Medical Recall Injected particulate matter may result in local inflammation, phlebitis, and/or low level allergic response. Company: Hospira, Inc. Pradaxa (dabigatran): Drug Safety Communication - Lower Risk for Stroke and Death, but Higher Risk for GI Bleeding Compared to Warfarin 05/13/2014 Medical Recall Study finds lower risk of clot-related strokes, bleeding in brain, and death for Pradaxia versus warfarin, but increased risk of major GI bleeding. Company: Pradaxa Datascope Corp/MAQUET, Certain Intra-Aortic Balloon Pumps: Recall - Potential Mechanical Failure of Power Supply Fan Assembly 05/12/2014 Medical Recall Failure 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. Company: Balloon Pumps Asset Bee Pollen: Public Notification - Undeclared Drug Ingredient 05/12/2014 Medical Recall Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients. Category Heart Alere INRatio2 PT/INR Professional Test Strips: Recall - Higher INR when Performed by Central Laboratory 05/07/2014 Medical Recall Therapeutic or near therapeutic INR with the test strips but a significantly higher INR when performed by a central laboratory. Company: Alere African Black Ant, Black Ant, and Mojo Risen by Eugene Oregon, Inc: Recall - Undeclared Drug Ingredient 05/07/2014 Medical Recall may contain undeclared amounts of sildenafil and tadalafil. Company: Eugene Oregon, Inc. Slim Trim U: Public Notification - Undeclared Drug Ingredient 05/06/2014 Medical Recall Risk of increased blood pressure and/or pulse rate. Category Heart Natural Body Solution: Public Notification - Undeclared Drug Ingredient 05/06/2014 Medical Recall Risk of increased blood pressure and/or pulse rate. Category Heart Abbott Acclaim and Hospira Acclaim Encore Infusion Pumps by Hospira, Inc: Class I Recall - Broken Door Assemblies 05/02/2014 Medical Recall May Result in Over-Infusion or Delay of Therapy. Company: Abbott Acclaim Infusion Pumps Gemstar Docking Station by Hospira, Inc: Class I Recall - Potential for Error or Failure to Power Up 05/02/2014 Medical Recall A delay or interruption in therapy has a worst case potential to result in significant injury or death. Company: GemStar Sigma Spectrum Infusion Pumps with Master Drug Library by Baxter Healthcare: Class I Recall - System Error May Interrupt or Delay Therapy 05/02/2014 Medical Recall Pump may stop the infusion, requiring a clinician to reset the alarm, reprogram the pump, and confirm the infusion is running properly. Company: Baxter Healthcare Flawless Beauty and Skin Products: Recall - Unapproved Drugs 04/30/2014 Medical Recall Risks include unknown quality, safety, and efficacy. Category Liver Biopsy GenStrip Blood Glucose Test Strips by Shasta Technologies: FDA Safety Communication - May Report False Results 04/29/2014 Medical Recall Recent FDA inspection of manufacturer found extensive violations of federal regulations intended to assure the quality of product. Company: Shasta Technologies LLC HeartWare, Inc., Heartware Ventricular Assist System: Class I Recall - Locking Mechanism of Pump Driveline Connector May Fail to Engage 04/29/2014 Medical Recall Failure could result in the pump stopping and lead to serious adverse health consequences, including death. Company: HeartWare, Inc. Super Arthgold by Nano Well-being Health: Recall - Undeclared Drug Ingredients 04/24/2014 Medical Recall Risk of myocardial infarction, stroke, congestive heart failure, renal toxicity, and bleeding, ulceration, or perforation of the stomach or intestines. Company: Nano Well-being Health Inc. Epidural Corticosteroid Injection: Drug Safety Communication - Risk of Rare But Serious Neurologic Problems 04/23/2014 Medical Recall Injection of corticosteroids into the epidural space of the spine may result in loss of vision, stroke, paralysis, and death. Category Health Care Marcaine (Bupivacaine HCI Injection, USP) 0.25 percent, 10 ml, Single-Dose, Preservative-Free Vial: Recall - Visible Particulates 04/22/2014 Medical Recall Injected particulate could result in local inflammation, mechanical disruption of tissue or immune response to the particulate. Company: Hospira Thinogenics Products by Nature’s Universe: Recall - Undeclared Drug Ingredient 04/18/2014 Medical Recall Use of undeclared sibutramine can lead to increased risk of seizures, heart attacks, arrhythmia and stroke. Company: Thinogenics Propofol Injectable Emulsion, USP by Hospira: Recall - Visible Particulates 04/18/2014 Medical Recall Injected 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. Company: Hospira S.W.A.G: Public Notification - Undeclared Drug Ingredient 04/18/2014 Medical Recall Contains undeclared Sildenafil, which may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Category Erectile Dysfunction CUBICIN (daptomycin for injection) by Cubist Pharmaceuticals: Recall - Presence of Particulate Matter 04/18/2014 Medical Recall Potential risk of thromboembolism, pulmonary emboli, phlebitis, mechanical block of the capillaries or arterioles, activation of platelets, subsequent generation of microthrombi, and emboli. Company: Cubicin Lidocaine HCI Injection, USP, by Hospira: Recall - Visible Particulates 04/18/2014 Medical Recall Risk of local inflammation, and/or mechanical disruption of tissue or immune response to the particulate, and/or a delay in therapy. Company: Stericycle Laparoscopic Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication - Use Discouraged Due to Increased Risk in Women With Uterine Fibroids 04/17/2014 Medical Recall If 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. Category Uterine Fibroids ARKON Anesthesia Delivery System with Version 2.0 Software by Spacelabs Healthcare: Class I Recall - Software Defect May Cause System to Stop Working 04/16/2014 Medical Recall Defect may cause serious adverse health consequences, including hypoxemia and death. Company: Spacelabs Healthcare Infinity: Public Notification - Undeclared Drug Ingredient 04/11/2014 Medical Recall Use 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. Company: Infinity Lite Fit USA: Public Notification - Undeclared Drug Ingredient 04/11/2014 Medical Recall Use 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. Company: Lite Fit USA March 2014 04/11/2014 Medical Recall Safety Labeling Changes includes 30 products with revisions to Prescribing Information. Posted 04/11/2014. Category File Format Covidien Pipeline Embolization Device and Alligator Retrieval Device: Recall - Coating on Delivery Wire Could Delaminate 04/11/2014 Medical Recall Use of affected products could potentially lead to embolic occlusion in the cerebral vasculature, with the risk of stroke and/or death. Company: Alligator Retrieval Devices Zi Xiu Tang Bee Pollen Capsules by Guangzhou Zi Xiu Tang Biotechnology Co., Ltd: Warning - Undeclared Drug Ingredients 04/08/2014 Medical Recall Risk of increased blood pressure and/or pulse rate. Company: Zi Xiu Tang Bee Pollen PS500 Power Supply Unit by Dräger: Recall - Early Depletion of Battery Charge 04/02/2014 Medical Recall Battery depletion will require manual ventilation until the device is connected to main power. Company: Dräger Revatio (sildenafil): Drug Safety Communication - FDA clarifies Warning About Pediatric Use for Pulmonary Arterial Hypertension 03/31/2014 Medical Recall Health care professionals must consider whether the benefits of treatment with the drug are likely to outweigh its potential risks for each patient. Company: FDAs Nova Products, Inc. Dietary Supplements: Recall - Undeclared Drug Ingredients 03/31/2014 Medical Recall Sildenafil and tadalafil can interact with nitrates found in some prescription drugs (such as nitroglycerin), resulting in decreased blood pressure. Company: Nova Products, Inc. Alli (60 mg orlistat capsules) by GlaxoSmithKline: Recall - Product Tampering 03/28/2014 Medical Recall Some packages of the product were tampered with and may contain product that is not authentic. Company: Alli Bella Vi Brand Products by Pure Edge Nutrition: Recall - Undeclared Drug Ingredients 03/26/2014 Medical Recall Sibutramine 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. Company: Pure Edge Nutrition New Life Nutritional Center Dietary Supplements: Recall - Undeclared Drug Ingredients 03/26/2014 Medical Recall Undeclared sibutramine and phenolphthalein make these products unapproved new drugs for which safety and efficacy have not been established. Company: New Life Nutritional Center Pleo Homeopathic Drug Products by Terra-Medica: Recall - Potential for Undeclared Penicillin 03/21/2014 Medical Recall Exposure to penicillin can result in a range of allergic reactions from mild rashes to severe and life-threatening anaphylactic reactions. Company: Terra-Medica February 2014 03/19/2014 Medical Recall Drug Safety Labeling Changes, February 2014 Category File Format Vitaccino Coffee: Public Notification - Undeclared Drug Ingredient 03/19/2014 Medical Recall Sibutramine 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. Company: Vitaccino Coffee Playtex Nurser Deluxe Double Electric Breast Pump: Recall - Potential for Electric Shock 03/19/2014 Medical Recall The casing on some AC/DC power adapters may become loose and separate, resulting in a potential for electric shock. Company: Playtex Nurser Hospira Hemostat Dual Channel Plum Set: Recall-Risk of over-delivery of blood products 03/18/2014 Medical Recall Over-delivery of blood products in the populations at greatest risk may result in injuries that require medical intervention. Company: Stericycle FreeStyle and FreeStyle Flash Blood Glucose Meter by Abbott: Recall - May Produce Mistakenly Low Blood Glucose Results 03/17/2014 Medical Recall Symptoms of high blood sugar include excessive thirst, excessive urination, blurred vision, weakness, nausea, vomiting and abdominal pain. Category Glucose Meter McKesson Technologies Anesthesia Care: Recall – Patient Case Data May Not Match Patient Data 03/15/2014 Medical Recall Class 1 recall of computer-based system. Company: McKesson Technologies Anesthesia Care VPRIV (velaglucerase alfa for injection): Recall - Visible Particulate Matter 03/14/2014 Medical Recall Risk of rare but serious adverse events associated with infusion containing particulates. Company: Shire Pharmaceuticals Reumofan Plus: Recall - Undeclared Drug Ingredient 03/14/2014 Medical Recall UPDATED 03/14/2014. Pain Free by Nature is voluntarily recalling all lots of Reumofan Plus Tablets. Originally posted 06/01/2012. Company: Reumofan Plus Merit Medical Systems, Custom Procedural Trays/Kits Containing 1 percent Lidocaine HCl Injection, USP, 10mg/mL: Recall - Particulates Found in Hospira supplied Lidocaine 03/14/2014 Medical Recall Presence 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. Company: Merit Medical Greatbatch, Inc. Standard Offset Cup Impactors: Recall - Sterilization Recommendation in Instructions Do Not Meet Sterility Assurance Requirements 03/12/2014 Medical Recall Lack of sterility assurance has the potential to result in surgical infection. Company: Greatbatch Inc. Effexor XR 150 Mg Extended-Release Capsules (Pfizer) and Venlafaxine HCl 150 Mg Extended-Release Capsules (Greenstone): Recall - Possible Presence of Tikosyn Capsules 03/07/2014 Medical Recall The use of Tikosyn by an Effexor XR/Venlafaxine HCl patient could cause serious adverse health consequences that could be fatal. Company: Pfizer Inc. Doribax (doripenem): Drug Safety Communication - Risk When Used to Treat Pneumonia on Ventilated Patients 03/07/2014 Medical Recall Increased risk of death and lower clinical cure rates compared to use of imipenem and cilastatin. Category Health Care DIANEAL PD-2 Peritoneal Dialysis Solution with 1.5 Percent Dextrose 6000mL: Recall - Contamination With Mold 03/07/2014 Medical Recall Administration of a product contaminated with mold could result in life-threatening fungal peritoneal infection or sepsis. Company: Baxter International HeartMate II LVAS Pocket System Controller by Thoratec Corporation: Medical Device Correction - Updated Labeling and Training Materials 03/05/2014 Medical Recall Reports 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. Company: Thoratec Corporation GE Healthcare Resuscitation Systems: Class I Recall - Oxygen and Air Inlet Fittings Reversed During Assembly 02/28/2014 Medical Recall Recalled 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. Company: GE Healthcare ACME Monaco Guidewire .035x150 3MMJ TCFC, Item 88241 by Medline Industries: Class I Recall - Potential for Coating to Flake Off 02/25/2014 Medical Recall Use of this recalled product may result in serious adverse health consequences. Company: ACME Monaco Guidewire 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 Use 02/24/2014 Medical Recall If a tracheal tube kinks, it can deprive the patient of adequate ventilation causing serious patient injury including hypoxic injury and/or anoxia, and death. Category Patient Etomidate Injection/Pfizer-Mylan: Recall - Presence of Particulate Matter and/or Illegible and Missing Lot Number and/or Expiry Date 02/20/2014 Medical Recall Intravenous administration of particles may lead to impairment of microcirculation, phlebitis, infection, embolism and subsequent infarction. Company: Agila Specialties Trilogy Ventilator Models 100, 200 and 202 by Philips Respironics: Recall - Failure to Deliver Mechanical Breaths 02/20/2014 Medical Recall Potential ventilator failure and reduced alarm functionality may result in serious adverse health consequences or death. Company: Philips Acetylcysteine Solution 10 Percent: Recall - Glass Particles in Product 02/15/2014 Medical Recall Use 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. Company: Ben Venue Laboratories Reduce Weight Fruta Planta: Recall - Undeclared Drug Ingredient 02/14/2014 Medical Recall Consumption of this product could include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use. Category File Format L-citrulline by Medisca: Alert - Potentially Subpotent Product 02/14/2014 Medical Recall Subpotent L-citrulline in patients with certain urea cycle defects can lead to high ammonia levels, which is serious and potentially life-threatening. Company: Medisca Inc Saxagliptin (marketed as Onglyza and Kombiglyze XR): Drug Safety Communication - FDA to Review Heart Failure Risk 02/11/2014 Medical Recall FDA 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. Company: Onglyza Calcium gluconate 10 percent Injections by Rx Formulations: Recall - Microbial Contamination 02/07/2014 Medical Recall FDA testing confirmed the presence of gram-positive rod bacteria in the product, which can cause infection in patients. Company: Rx Formulations Testosterone Products: Drug Safety Communication - FDA Investigating Risk of Cardiovascular Events 01/31/2014 Medical Recall FDA assessing safety issues based on two separate studies that suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy. Category Health Care Mega Slim Herbal Appetite Management Pills by YoungYou International: Recall - Presence of DMAA 01/31/2014 Medical Recall DMAA may cause a rise in blood pressure or other cardiovascular problems such as shortness of breath, tightening in the chest or heart attack. Company: DMAA Trufill n-BCA Liquid Embolic System by Codman Neuro: Recall - Incorrect Instructions For Use 01/22/2014 Medical Recall Incorrectly 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. Company: Codman Neuro Dream Body Slimming Capsule: Public Notification - Undeclared Drug Ingredient 01/22/2014 Medical Recall Sibutramine 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. Category Myocardial Infarction Magic Slim: Public Notification - Undeclared Drug Ingredient 01/22/2014 Medical Recall Sibutramine 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. Category Hypertension StemAlive 90 Capsules: Recall - Contains Undeclared Milk 01/20/2014 Medical Recall Risk of serious or life-threatening allergic reaction. Company: StemAlive Rohto Eye Drops - Mentholatum: Recall - Sterility Control Review 01/17/2014 Medical Recall Production facility in Vietnam reviewing manufacturing sterility controls. Company: The Mentholatum Company Acetaminophen Prescription Combination Drug Products with more than 325 mg: FDA Statement - Recommendation to Discontinue Prescribing and Dispensing 01/15/2014 Medical Recall Inadvertent 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. Category Health Care t:slim Insulin Cartridges by Tandem Diabetes Care: Recall - Potential for Cartridge Leak 01/14/2014 Medical Recall Cartridge leak could potentially result in the device delivering too much or too little insulin. Company: Tandem Diabetes Care Pro ArthMax by Human Science Foundation: Recall - Undeclared Drug Ingredients 01/14/2014 Medical Recall Undeclared Chlorzoxazone, Nefopam, Diclofenac, Ibuprofen, Naproxen, and Indomethacin. Pro ArthMax has a reasonable probability of resulting in fatal adverse events. Company: Nefopam 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 Ingredients 01/10/2014 Medical Recall Analysis 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. Company: Midwest Wholesale Puritan Bennett 840 Series Ventilator by Covidien - Class I Recall - Software Problem 01/10/2014 Medical Recall Ventilator may stop functioning, triggering the safety alarm and causing the patient to suddenly be required to breathe on his or her own. Company: Covidien December 2013 01/10/2014 Medical Recall Safety Labeling Changes includes 39 products with revisions to Prescribing Information. Category The Legend Of Zelda: A Link To The Past Sodium Phosphate Over-the-Counter Products: Drug Safety Communication - Possible Harm From Exceeding Recommended Dose 01/08/2014 Medical Recall Reports 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. Category Health Care Truebalance and Truetrack Blood Glucose Meters by Nipro Diagnostics: Recall - Incorrect Factory-set Measure 01/08/2014 Medical Recall If 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. Company: Nipro Diagnostics SafeSpout and SafeShower Filtration Products by Nephros: Class I Recall - Exposure to Bacteria or Virus 01/07/2014 Medical Recall The 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. Company: Nephros Filtration Products Nephros Filtration Products: Class I Recall - Labeling Promoting Medical Claims 01/07/2014 Medical Recall Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device. Company: DSU CLINIMIX and CLINIMIX E Injection/Baxter: Recall - Particulate Matter in Products 01/06/2014 Medical Recall If 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. Category Protein CO2 Multi Absorber by Vital Signs Devices: Field Corrective Action - Loss of Anesthetic Gases, Ventilation and Oxygenation 01/01/2014 Medical Recall A potential safety issue due to air leakage associated with the CO2 Multi Absorber. Company: GE Healthcare Company Baxter 5 Percent Dextrose Injection, USP And 0.9 Percent Sodium Chloride Injection, USP Intravenous (IV) Solutions: Recall - Particulate Matter In Solution 12/27/2013 Medical Recall Injecting 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. Company: USP Burn 7 Capsules by Deseo Rebajar: Recall - Undeclared Drug Ingredient 12/24/2013 Medical Recall Undeclared Sibutramine, known to substantially increase blood pressure and/or pulse rate in some patients. Company: Deseo Rebajar Inc. Lidocaine HCl Injection 2%, 5 ml Vial by Hospira: Recall - Presence of Particulate Matter 12/24/2013 Medical Recall If infused, particulate matter could lead to local inflammation, tissue trauma, mechanical disruption of tissue, and/or local granuloma formulation. Company: Stericycle Muscle Growth Product Called Mass Destruction: FDA Health Risk Warning - Undeclared Ingredients 12/23/2013 Medical Recall The product is labeled to contain at least one synthetic anabolic steroid and has been linked to at least one reported serious illness. Company: Blunt Force Nutrition Abrams Royal Pharmacy Sterile Products - Recall - Lack of Sterility Assurance 12/19/2013 Medical Recall Use of Microbial contamination in products intended to be sterile can put patients at risk for serious, potentially life-threatening infections. Category Health Care Provider Methylphenidate ADHD Medications: Drug Safety Communication - Risk of Long-lasting Erections 12/17/2013 Medical Recall Prolonged erections (priapism) can lead to permanent damage to the penis. Category Attention Deficit Hyperactivity Disorder Soliris (Eculizumab) Concentrated Solution for Intravenous Infusion by Alexion: Recall - Visible Particles 12/16/2013 Medical Recall Two lots were found to contain visible particles. Particulates could cause blockage of flow of blood in vessels, which could be life-threatening. Company: Alexion Pharmaceuticals, Inc. Nipple Aspirate Test: Safety Communication - Breast Cancer Screening Test Is Not An Alternative To Mammography 12/12/2013 Medical Recall Misleading 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. Category Cancer Onfi (clobazam): Drug Safety Communication - Risk of Serious Skin Reactions 12/03/2013 Medical Recall Cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) Reported. Category Medicine HeartStart Automated External Defibrillators (AED) From Philips Healthcare: Safety Communication - Failure Of An Electrical Component That Could Cause AEDs To Fail To Deliver Appropriate Shock 12/03/2013 Medical Recall When normal heart rhythms are not restored quickly, sudden cardiac arrest can cause death. Company: Philips Medical Systems Hydravax Dietary Supplement by IQ Formulations: Recall - Possible Undeclared Drug Ingredient 12/01/2013 Medical Recall Sample 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. Company: Hydravax FreeStyle and FreeStyle Lite Blood Glucose Test Strips by Abbott: Recall - Erroneously Low Blood Glucose Results 11/28/2013 Medical Recall Falsely 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. Category Customer Service Nitroglycerin in 5% Dextrose Injection by Baxter: Recall - Particulate Matter 11/27/2013 Medical Recall Voluntary 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. Company: Baxter International Inc Spacelabs Healthcare, Inc., Spacelabs Anesthesia Workstations and Service Kits: Class I Recall - Bag-to-Vent Switch in CAS I/II Absorbers May Fail 11/26/2013 Medical Recall Potential for a large leak from the absorber circuit while operating in bag mode and could impede the ability to provide ventilation in bag mode. Company: Spacelabs Healthcare CLR Medicals International Inc. Viscoelastic Products: Recall - Quality System Deficiencies And Lack Of Premarket Approval (PMR) 11/26/2013 Medical Recall Clinical consequences associated with use of the contaminated and/or adulterated products may include intraocular infection, inflammation and elevated intraocular pressure. Company: CLR Medicals International Inc. Rosiglitazone-containing Diabetes Medicines: Drug Safety Communication - Removal of Some Prescribing and Dispensing Restrictions 11/25/2013 Medical Recall Health 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. Company: Dear Healthcare Provider Hospira GemStar Infusion System: Class I Recall - Pressure Sensor Calibration Drift 11/25/2013 Medical Recall May 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. Company: Hospira Meridian Medical Technologies Auto-Injectors: Extension of Expiration Dates 11/22/2013 Medical Recall FDA is currently reviewing data for the potential use of these auto-injectors beyond their labeled expiration dates, in order to mitigate any potential shortages. Company: Meridian Adipotrim XT by Deseo Rebajar: Recall - Undeclared Drug Ingredient 11/21/2013 Medical Recall Undeclared Fluoxetine, a selective serotonin reuptake inhibitor (SSRI). Use of SSRIs have been associated with serious side effects including suicidal thinking, abnormal bleeding, and seizures. Company: Adipotrim XT Lexiscan (regadenoson) and Adenoscan (adenosine): Drug Safety Communication - Rare but Serious Risk of Heart Attack and Death 11/20/2013 Medical Recall Cases of myocardial infarction and death have occurred following the administration of Lexiscan (regadenoson) injection or Adenoscan (adenosine) infusion. Company: Lexiscan P-Boost, NatuRECT by Tendex: Recall - Undeclared Drug Ingredient 11/20/2013 Medical Recall Undeclared tadalafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to unsafe levels. Company: NatuRECT RezzRX: Recall - Undeclared Drug Ingredients 11/19/2013 Medical Recall Undeclared 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. Company: Fossil Fuel Products Rhino 5 Plus, Maxtremezen and Extenzone: Recall - Undeclared Drug Ingredients 11/19/2013 Medical Recall Undeclared 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. Company: Jobbers Wholesale Nature's Pharmacy and Compounding Center Sterile Compounded Products: Recall - Lack of Sterility Assurance 11/16/2013 Medical Recall In the event a sterile product is compromised, patients are at risk for very serious infections. Category Health Care Provider New Reliance Traders, Inc. Special Eyeliner: Recall - Elevated Lead Levels 11/16/2013 Medical Recall Recent analysis of the product found that the products contained lead levels high as 167387 parts per million (ppm) Company: New Reliance Traders Medtronic Guidewires: Recall - Potential For Coating On Surface To Delaminate And Detach 11/16/2013 Medical Recall Some Medtronic models of its guidewires from recent lots have the potential for the coating on their surface to delaminate and detach. Company: Medtronic VitaliKOR Fast Acting: Recall - Undeclared Drug Ingredients 11/15/2013 Medical Recall Undeclared Vardenafil and Tadalafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to unsafe levels. Company: Vitality Research Labs Over-the-Counter Topical Antiseptic Products: Drug Safety Communication - FDA Requests Label Changes and Single-Use Packaging to Decrease Risk of Infection 11/13/2013 Medical Recall Clinical 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. Category Antiseptic Vega One Nutritional Shakes and Vega Sport Performance Protein: Recall - Traces of Antibiotic 11/12/2013 Medical Recall Risk of aplastic anemia and allergic reactions. Company: Sequel Naturals Inc. OxyElite Pro Dietary Supplements by USP Labs: Recall - Products Linked to Liver Illnesses 11/10/2013 Medical Recall The products contained aegeline, a new dietary ingredient that lacks a history of use or other evidence of safety. Company: OxyElite Pro Baylis Medical TorFlex Transseptal Guiding Sheath Kit: Class I Recall - Sheath Could Remove Particulate 11/06/2013 Medical Recall Particulate could potentially migrate into a patient’s bloodstream. Company: Baylis Medical Company Low Molecular Weight Heparins: Drug Safety Communication - Recommendations to Decrease Risk of Spinal Column Bleeding and Paralysis 11/06/2013 Medical Recall All anticoagulants carry the risk of causing epidural or spinal hematomas when used in conjunction with epidural/spinal anesthesia or spinal puncture. Company: Lovenox Edwards Lifesciences LLC, EMBOL-X Glide Protection System: Class I Recall - Deformed Cannula Tip 11/04/2013 Medical Recall Use of defective product may lead to tip separation and embolization. Company: Edwards Lifesciences LLC Perrigo Acetaminophen Infant Suspension Liquid: Recall - Potential Defect with Co-packaged Oral Syringe 11/02/2013 Medical Recall Using 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 Company: The Perrigo Company September 2013 11/01/2013 Medical Recall September 2013 drug safety labeling changes Category The Legend Of Zelda: A Link To The Past Potiga (Ezogabine): Drug Safety Communication - Linked To Retinal Abnormalities And Blue Skin Discoloration 11/01/2013 Medical Recall UPDATE: Boxed Warning and other labeling changes approved. Company: Potiga PENTAX Medical Gas/Water Valves, Model OF-B194: Recall - Manufacturing Defect 11/01/2013 Medical Recall May 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. Company: PENTAX Medical Company MedStream Programmable Infusion Pump and Refill Kits by Codman and Shurtleff: Class 1 Recall - Drug Over Infusion 10/23/2013 Medical Recall Air in the pump reservoir may release a higher dosage of drug than expected, leading to drug overdose. Company: Codman & Shurtleff, Inc. Specialty Medicine Compounding Pharmacy Certain Unexpired Compounded Sterile Products: Recall - Particulate Matter Found in Vials 10/21/2013 Medical Recall If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections. Posted 10/21/2013 Category Health Care Provider Bard LifeStent Solo Vascular Stent: Class 1 Recall - Failure to Deploy 10/18/2013 Medical Recall Serious adverse health consequences, including complications of bleeding, loss of limb, heart attack, or stroke. Category Myocardial Infarction Albuterol Sulfate Inhalation Solution, 0.083 percent (Nephron Pharmaceuticals): Recall - Aseptic Processing Simulation Results 10/17/2013 Medical Recall Finding of bacterial growth. Company: Nephron Pharmaceuticals St. Jude Amplatzer Atrial Septal Occluder (ASO): Safety Communication - Reports of Tissue Erosion 10/17/2013 Medical Recall Tissue surrounding the Amplatzer ASO can break down (erode) and result in life-threatening emergencies that require immediate surgery. Company: Amplatzer ASO Engström Ventilator, Aespire View, Aisys, And Avance Anesthesia Machines: Voluntary Field Corrective Action - Potential Safety Issue 10/16/2013 Medical Recall May result in the inability to access certain menu functions which could possibly lead to delay in treatment. Company: GE Healthcare Avance, Aisys And Avance CS2 Anesthesia Delivery Systems: Voluntary Field Corrective Action - Potential Safety Issue 10/15/2013 Medical Recall A unique sequence of inputs and a collapsed bellow could result in delivery of higher-than-expected tidal volume. Company: GE Healthcare Inclusig (Ponatinib): Drug Safety Communication - Increased Reports Of Serious Blood Clots In Arteries And Veins 10/11/2013 Medical Recall Health care professionals should consider for each patient, whether the benefits of Iclusig treatment are likely to exceed the risks of treatment. Company: Iclusig Perfect Body Solutions and Burn 7: Public Notification - Undeclared Ingredients 10/10/2013 Medical Recall May increase blood pressure and/or pulse rate and can present a significant risk for patients with a history certain cardiovascular conditions or stroke. Company: Perfect Body Solutions Dr. Mao Slimming Capsules: Public Notification - Undeclared Ingredients 10/10/2013 Medical Recall May increase blood pressure and/or pulse rate and can present a significant risk for patients with a history certain cardiovascular conditions or stroke. Category Blood Pressure Bella Vi Insane Amp’d And Bella Vi Amp’d Up: Public Notification - Undeclared Ingredients 10/10/2013 Medical Recall May increase blood pressure and/or pulse rate and can present a significant risk for patients with a history certain cardiovascular conditions or stroke. Company: Bella Vi Amp Be Inspired: Public Notification - Undeclared Ingredients 10/10/2013 Medical Recall May increase blood pressure and/or pulse rate and can present a significant risk for patients with a history certain cardiovascular conditions or stroke. Category Health Care Slim Fortune, Lidiy And Slim Expert Dietary Supplement: Recall - Undeclared Ingredients 10/09/2013 Medical Recall May substantially increase blood pressure and/or pulse rate or present a significant risk for patients with a history of certain cardiovascular conditions or stroke. Company: Slim Fortune Cefepime For Injection, USP And Dextrose Injection, USP By B. Braun Medical Inc.: Recall - Visible Particulate Matter 10/08/2013 Medical Recall May illicit inflammatory responses, both chronic and acute, and may be life threatening. Company: Braun Medical Inc. OxyElite Pro: Health Advisory - Acute Hepatitis Illness Cases Linked To Product Use 10/08/2013 Medical Recall FDA advises consumers to stop using products labeled OxyElite Pro while the investigation continues. Company: OxyElite Pro Fabius Anesthesia Machines: Recall - Did Not Pass High Voltage Test Portion Of Final Production Test 10/08/2013 Medical Recall In extreme cases, may cause a failure of the automatic ventilation function of the device. Company: Fabius GS Premium Breast Health Test and Mammary Aspiration Specimen Cytology Test: Recall - Instructions For Use, Promotional Claims and FDA Clearance Concerns 10/05/2013 Medical Recall Atossa will remove existing product from the market until concerns are addressed. Company: Atossa 1% Lidocaine HCL Injection By Hospira: Recall - Presence Of Dark Particulate 10/05/2013 Medical Recall May 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. Company: Hospira Emergency Cricothyrotomy Kit By H&H Medical Corporation: Recall - Defective Cuff Balloon On Endotracheal Airway 10/04/2013 Medical Recall Defect 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. Company: H&H Medical Corporation Metoclopramide Injection And Ondansetron Injection by Hospira: Recall - Glass Strand Particulates Caused By Glass Supplier 10/02/2013 Medical Recall Administration of an injectable with the presence of foreign particulates may result in local inflammation, thrombophlebitis, and/or low-level allergic response. Company: Hospira Virilis Pro, PHUK and Prolifta Capsules : Recall - Undeclared Ingredients 10/01/2013 Medical Recall Potential to interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to unsafe levels. Company: Virilis Pro Carefusion Avea Ventilator: Recall - Underreporting Of Tidal Volume If Used In Conjunction With Neonatal Hotwire Flow Sensor 10/01/2013 Medical Recall Patients may receive a higher than expected tidal Company: CareFusion Afikim Electric Vehicles Issues Nationwide Recall Of Breeze C Scooter: Recall - Potential For Malfunction 10/01/2013 Medical Recall May become unresponsive during operation, resulting in the driver not being able to stop the scooter during operation. Company: Afikim Electric Vehicles Tygacil (tigecycline): Drug Safety Communication - Increased Risk of Death 09/27/2013 Medical Recall BOXED WARNING describes risk for FDA-approved and non-approved uses. Company: Tygacil The Compounding Shop: FDA News Release - Lack of Sterility Assurance of Drug Products 09/27/2013 Medical Recall UPDATED 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 Company: The Compounding Shop W.S. Badger Company Daily SPF 30 Kids & Baby Sunscreen Lotion: Recall - Microbial Contamination 09/25/2013 Medical Recall Lab testing found certain product lots were contaminated with Pseudomonas aeruginosa, Candida parapsilosis and Acremonium fungi. Company: W.S. Badger Co. Inc. Arzerra (ofatumumab) and Rituxan (rituximab): Drug Safety Communication - New Boxed Warning, Recommendations to Decrease Risk of Hepatitis B Reactivation 09/25/2013 Medical Recall Hepatitis B reactivation occurred in patients with prior HBV exposure and later treated with Arzerra & Rituxan. Cases of fulminant hepatitis, hepatic failure, and death reported. Category Hepatitis B Xzen 1200, Xzen Gold and Xzen XPress: Public Notification - Undeclared Ingredients 09/24/2013 Medical Recall May interact with nitrates found in some prescription drugs lower blood pressure to dangerous levels. Company: Xzen XPress XZone Premium: Public Notification - Undeclared Drug Ingredient 09/24/2013 Medical Recall Contains 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. Category Erectile Dysfunction Wood-E: Public Notification - Undeclared Drug Ingredient 09/24/2013 Medical Recall Contains sildenafil, which may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Category Erectile Dysfunction Duragesic (fentanyl) Patches: Drug Safety Communication - Packaging Changes to Minimize Risk of Accidental Exposure 09/23/2013 Medical Recall Accidental exposure to fentanyl can cause serious harm and death in children, pets, and others. Category Fentanyl Baxter Dual Luer Lock Caps: Class I Recall - Presence of Loose Particulate Matter Found In Packaging 09/20/2013 Medical Recall May result in thrombotic and embolic events, including: pulmonary embolism, myocardial infarction and stroke. Company: Baxter International Inc. Shou Fu Ti Tun Guo Xiang Xing Jian Fei Jiao Nang: Public Notification - Undeclared Drug Ingredient 09/17/2013 Medical Recall May 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. Category Hypertension HeartSine Technologies Samaritan 300/300P PAD Public Access Defibrillators: Recall - Power, Battery Issues 09/17/2013 Medical Recall Two separate issues may affect the ability to deliver therapy to a patient in a sudden cardiac arrest event. Company: HeartSine Technologies 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 Matter 09/14/2013 Medical Recall One 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. Company: Bupivacaine HCl Creafuse Powder Grape and Creafuse Powder Fruit Punch: Recall - Contains DMAA 09/13/2013 Medical Recall Ingestion of DMAA can elevate blood pressure and lead to cardiovascular problems. Company: Ge Pharma Leiter's Compounding Pharmacy: Recall - Concerns of Sterility Assurance 09/12/2013 Medical Recall Use of a non-sterile injectable product exposes patients to the risk of contracting serious life-threatening infections. Company: Compounding Pharmacy Park Compounding Sterile Medication: Recall – Concerns of Sterility Assurance 09/10/2013 Medical Recall If there is microbial contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening. Company: Front Range Laboratories Avella Specialty Pharmacy Sterile Medications: Recall - Concerns Of Sterility Assurance At Testing Vendor 09/09/2013 Medical Recall If microbial contamination occurs in medications intended to be sterile, patients are at risk of serious infections that may be life threatening. Company: Avella Specialty Pharmacy MOTRIN Infants Drops Original Berry Flavor 1/2 fl oz: Recall - Particles Identified 09/08/2013 Medical Recall May contain tiny plastic particles. Company: McNeil Consumer Healthcare University Compounding Pharmacy Injection Products: Recall - Lack of Sterility Assurance 09/08/2013 Medical Recall If there is microbial contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening. Company: Sesame Oil Altaire Pharmaceuticals Carboxymethylcellulose Sodium 0.5 Percent Ophthalmic Solution Sold Under Wal-Mart, CVS, and Target Brands: Recall - Preservative May Not Be Effective Through Expiry 09/08/2013 Medical Recall Potential risk for eye infection. Company: Altaire Pharmaceuticals, Inc. Medaus Pharmacy Sterile Compounded Products - Recall: Inability to Confirm Sterility 09/05/2013 Medical Recall Questions Surrounding an Independent Third Party's Sterility Testing Company: Medaus Pharmacy Siemens MicroScan Synergies Plus And MicroScan RapID/S Plus Negative Panels: Class I Recall - False Susceptible And False Intermediate Results 09/04/2013 Medical Recall Defect may lead to treatment with an inappropriate antibiotic or a delay in initiating appropriate therapy. Company: Siemens Aminosyn II 10 percent, Sulfite-Free (Hospira): Recall - Particulate Matter Noted in One Lot 09/03/2013 Medical Recall Particle confirmed by Hospira as human hair. Company: Hospira Cubicin (daptomycin for injection): Recall - Glass Particulate Matter Present in Four Lots 08/29/2013 Medical Recall Risk of thromboembolism and pulmonary emboli, some life-threatening. Category File Format Gilenya (fingolimod) - Drug Safety Communication: Investigating Rare Brain Infection 08/29/2013 Medical Recall Patient has developed a rare and serious brain infection after taking the drug. Company: Novartis Stryker Spine: Class 1 Recall - OASYS Midline Occiput Plate 08/29/2013 Medical Recall Post-operative fracture of the pin that connects the head to the plate body. Company: OASYS Pro Power Max, Evil Root and 72HP By Hardmenstore.com: Recall - Undeclared Ingredient 08/28/2013 Medical Recall May interact with nitrates found in some prescription drugs,lower blood pressure to dangerous levels or cause side effects, such as headaches and flushing. Category Hypertension Wellness Pharmacy, Inc. Products: Recall - Laboratory Results Indicating Microbial Contamination 08/27/2013 Medical Recall If there is microbial contamination in medications intended to be sterile, patients are at risk of serious infections which may be life threatening. Company: Wellness Pharmacy JCB Laboratories Products: Recall - Sterility Assurance at Testing Vendor 08/27/2013 Medical Recall If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections. Company: JCB Laboratories Compounded Sterile Preparations By Park Pharmacy & Compounding Center: Recall - Lack of Sterility Assurance 08/27/2013 Medical Recall Methods used by the laboratory to assess sterility may have resulted in pharmacies receiving inaccurate laboratory test results. Category Pharmacy Ortiga Contains Hidden Drug Ingredient 08/22/2013 Medical Recall FDA laboratory analysis confirmed that Ortiga contains the prescription drug ingredient, diclofenac. Company: Ortiga Jack Rabbit Dietary Supplement: Recall - Undeclared Drug Ingredients 08/21/2013 Medical Recall Undeclared Sildenafil and Tadalafil may interact with nitrates found in some prescription drugs such as nitroglycerin, and may lower blood pressure to dangerous levels. Company: Jack Rabbit Inc. Covidien Monoject Prefill Flush Syringes: Recall - Not Subjected To AutoClave Sterilization Process Or Mismatched Syringe Tip Cap, Syringe Label, Filled Volume And Wrapper 08/20/2013 Medical Recall Health risk of life-threatening infection to the blood stream or patency of device may not be maintained and clotting may occur. Company: Covidien Esbelder Man Capsules, Esbelder Fem Capsules, And Esbelder Siloutte Capsules Vitamin Supplements By Herbal Give Care LLC: Recall - Undeclared Ingredients 08/20/2013 Medical Recall May substantially increase blood pressure and/or pulse rate as well as present significant other health risks for patients. Company: Herbal Give Care LLC Aidapak Services LLC, Select Repackaged Pharmaceuticals: Recall - Potential Incorrect Labeling 08/17/2013 Medical Recall Aidapak Services LLC, Specific Unit Dose Repackaged Products: Recall - Potential Incorrect Labeling Company: Aidapak Services LLC Fluoroquinolone Antibacterial Drugs: Drug Safety Communication- Risk for possibly permanent nerve damage 08/15/2013 Medical Recall The risk of peripheral neuropathy occurs only with fluoroquinolones that are taken by mouth or by injection. Company: Medication Guides Hospira Blood Sets: Recall - Instances Of Outer Wall Of Blood Bags Punctured With Piercing Pin 08/14/2013 Medical Recall Spillage of the blood and blood products stored in the bag may result in delay/interruption in therapy or exposure to the healthcare professional. Company: Hospira 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 Rate 08/12/2013 Medical Recall Increased 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. Company: Infusion Pumps Specialty Compounding Sterile Products: FDA Alert - Bacterial Infections 08/09/2013 Medical Recall Bacterial infections have been potentially associated with contaminated calcium gluconate infusions. Company: Specialty Compounding, LLC Cordis Optease Retrievable Inferior Vena Cava (IVC) Filter: Recall - Labeling Correction 08/08/2013 Medical Recall The company is making corrections and improvements to the device labeling to minimize likelihood of implanting the filter backwards. Company: Cordis CareFusion Alaris PC unit (model 8015) with version 9.12 Keyboard Processor: Class I Recall - Potential Loss of Communication Between Main Processor and Keyboard 08/07/2013 Medical Recall Device malfunction can result in the sudden unintended discontinuation of medications. This can lead to cause serious adverse health consequences, including death. Company: CareFusion Tranquility by Health and Beyond, LLC: Recall - Undeclared Drug Ingredient 08/07/2013 Medical Recall Consuming this product potentially could result in dizziness and cause public health risk. Company: Beyond LLC BEST SLIM 40 Pills By CTV Best Group: Recall - Undeclared Ingredients 08/06/2013 Medical Recall Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk. Company: CTV Bethel Advance And Quick Thin Products By Bethel Nutritional Consulting, Inc.: Recall - Undeclared Ingredients 08/06/2013 Medical Recall Sibutramine and Phenolphthalein may pose health threats or interact in life-threatening ways with other medications a consumer may be taking. Company: Bethel Nutritional Consulting, Inc. Benztropine Mesylate Injection (Nexus Pharmaceuticals): Recall - Visible Particulate Matter 08/02/2013 Medical Recall Risk of thromboembolism, some life-threatening (such as pulmonary emboli), as well as other serious adverse events. Company: Nexus Pharmaceuticals Inc. Acetaminophen: Drug Safety Communication - Association with Risk of Serious Skin Reactions 08/01/2013 Medical Recall Events are rare but can be fatal. Category Non Steroidal Anti Inflammatory Drug DePuy Orthopaedics-LPS Lower Extremity Dovetail Intercalary Component: Class 1 Recall - Potential for Fracture of Device 08/01/2013 Medical Recall Patients weighing more than 200 pounds and/or those with high levels of activity are at higher risk. Company: DePuy Orthopaedics Beacon Hill Medical Pharmacy/Rxtra Solutions: Recall - Lack of Sterility Assurance 08/01/2013 Medical Recall Sterile compounded products distributed nationwide Company: Beacon Hill/Rxtra Solutions Nova Max Glucose Test Strips: Recall - May Report False, Abnormally High Blood Glucose Result 07/29/2013 Medical Recall A false test result may lead to an insulin dosing error that could lead to a serious health risk requiring immediate medical attention. Company: Nova Diabetes Care Mefloquine Hydrochloride: Drug Safety Communication - Label Changes Due To Risk of Serious Psychiatric and Nerve Side Effects 07/29/2013 Medical Recall Effects from use may include dizziness, loss of balance, ringing in the ears, feeling anxious, mistrustful, or depressed, or having hallucinations. Company: Lariam GE Healthcare Nuclear Medicine Systems: Class I Recall - Serious Injuries or Deaths Could Occur 07/29/2013 Medical Recall Facilities are instructed to cease use of their Nuclear Medicine system until a GE Engineer is able to do a complete inspection of the system Company: GE Healthcare Nizoral (ketoconazole): Drug Safety Communication - Potentially Fatal Liver Injury, Risk of Drug Interactions and Adrenal Gland Problems 07/26/2013 Medical Recall Nizoral 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. Category Pharmacology Healthy Life Chemistry By Purity First B-50: FDA Health Risk Warning - Undeclared Ingredients 07/26/2013 Medical Recall Using anabolic steroid-containing products may cause acute liver injury and some of the cases reported have resulted in hospitalization. Category Nutrition LeMaitre Vascular, Inc., Albograft Vascular Graft: Class I Recall - Blood Leak 07/24/2013 Medical Recall Use of this product may cause serious adverse health consequences, including death. Category Adverse Event Diabetes Treatments: FDA Alerts of Illegal Sales - Undeclared Ingredients 07/23/2013 Medical Recall Some 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 Sensor 07/23/2013 Medical Recall The recommended pump refill date, computed by the Control Unit, may be incorrect. Company: Codman Esbelin Silouttte Te and Esbelin Siloutte Vitamin Supplement: Recall - Undeclared Drug Ingredients 07/23/2013 Medical Recall These products pose a health threat to Consumers because Sibutramine is known to increase blood pressure and/or pulse rate and other related health risks. Company: Herbal Give Care LLC Bryan Medical Tracoe Mini 3.0mm Tracheostomy Tube: Class 1 Recall - Mislabeled Packaging 07/22/2013 Medical Recall Using an oversized tracheostomy tube may cause permanent injury to the trachea. Category Vertebrate Trachea Volcano Male Enhancement Liquid and Volcano Male Enhancement Capsules: Recall - Undeclared Drug Ingredients 07/22/2013 Medical Recall Lab tests revealed products contain PDE 5 inhibitors and other drug ingredients that can be life threatening. Company: Volcano Company Silver Sword and Clalis by hardmenstore.com: Recall - Undeclared Drug Ingredient 07/15/2013 Medical Recall Use of these products, which contain Sildenafil, can result in decreased blood pressure, light-headedness, and dizziness. Company: Clalis Medtronic MiniMed Paradigm Insulin Infusion Sets: Class 1 Recall - Potential for Over or Under Delivery of Insulin 07/12/2013 Medical Recall May result in hypoglycemia or hyperglycemia, which can be severe and lead to serious illness. Company: Medtronic 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 Failure 07/10/2013 Medical Recall Blade 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. Category Health Care Estarylla (norgestimate and ethinyl estradiol): Recall - Report of Placebo Tablet Present in Row of Active Tablets 07/05/2013 Medical Recall Risk of pregnancy. Company: Estarylla Olmesartan Medoxomil: Drug Safety Communication - Label Changes To Include Intestinal Problems (Sprue-Like Enteropathy) 07/03/2013 Medical Recall Enteropathy may develop months to years after starting olmesartan, and sometimes requires hospitalization. Company: ARB RECOMBIVAX HB (Hepatitis B Vaccine (Recombinant)) Adult Formulation by Merck Sharp and Dohme Corp.: Recall - Potential For Cracked Vials 07/03/2013 Medical Recall If vial is cracked, integrity of the vial and sterility of any product remaining could not be assured. Company: Merck & Co. Benztropine Mesylate Injection by Fresenius Kabi USA: Recall - Potential Presence Of Glass Particles 07/02/2013 Medical Recall If present, the administration of glass particulate poses a potential safety risk to patients. Company: Fresenius Kabi USA Medtronic SynchroMed Implantable Infusion System Devices: Class 1 Recalls - Feed Through Failure, Failure of Priming Bolus, and Catheter Occlusion 06/28/2013 Medical Recall Medtronic SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps and Sutureless Connector Intrathecal Catheter Products Recalled. Company: Medtronic JaDera and Xiyouji Qingzhi Dietary Supplements by Dolphin Intertrade Corp.: Recall - Undeclared Drug Ingredient 06/28/2013 Medical Recall Products 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. Company: Dolphin Intertrade Corp. Hydroxyethyl Starch Solutions: FDA Safety Communication - Boxed Warning on Increased Mortality and Severe Renal Injury and Risk of Bleeding 06/24/2013 Medical Recall FDA 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 Category Blood Oxyphen, Phentalene, Phen FX, and Red Vipers by Beta Labs, LTD: Recall - Contains DMAA 06/24/2013 Medical Recall Ingestion of DMAA can elevate blood pressure and lead to cardiovascular problems. Company: DMAA Medtronic Xomed NIM Trivantage EMG Endotracheal Tube: Class I Recall - Cuff Leak or Cuff Deflation When Inflation Valve Cap Inappropriately Removed 06/21/2013 Medical Recall Physician may need to re-inflate or replace deflated tube to ensure the continued breathing support of the patient. Company: Medtronic Respironics California, Inc. - Class 1 Recall: V60 Ventilators - Issue with software 06/20/2013 Medical Recall Ventilator support may be lost with potentially no audible alarm from the ventilator. Company: Philips Healthcare Enteric Coated Aspirin 81 mg Tablets by Advance Pharmaceutical Inc.: Recall of One Lot - May Contain Acetaminophen 500 mg Tablets 06/19/2013 Medical Recall Consumers may inadvertently take Acetaminophen 500 mg instead of Enteric Coated Aspirin 81 mg which may cause severe liver damage. Company: Advance Pharmaceutical Inc. Zyprexa Relprevv (Olanzapine Pamoate): Drug Safety Communication - FDA Investigating Two Deaths Following Injection 06/18/2013 Medical Recall Two 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 Procedures 06/18/2013 Medical Recall Use of this recalled product may cause serious adverse health consequences, including death. Posted 06/18/2013 Company: AFX Cybersecurity for Medical Devices and Hospital Networks: FDA Safety Communication 06/17/2013 Medical Recall Many medical devices contain configurable embedded computer systems that can be vulnerable to cybersecurity breaches. Category Health Care May 2013 06/13/2013 Medical Recall MedWatch May 2013 drug safety labeling changes Category Methylphenidate Main Street Family Pharmacy in Tennessee: FDA Alerts Health Care Providers of Adverse Reactions Associated with Steroid Injections 06/13/2013 Medical Recall UPDATED 06/13/2013. FDA identified the specific bacterial and fungal growth in two MPA lots. Originally posted 05/24/2013. Category Bacteria Warfarin 2 mg Tablets by Zydus Pharmaceuticals USA Inc.: Recall - Due to Oversized Tablets 06/12/2013 Medical Recall Ingestion 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. Company: Zydus Pharmaceuticals USA Inc. © Copyright 2019 Edentech Solutions Group, LLC.

Drug and Medical Device Recalls Archive

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