The infusion pumps deliver fluids and medications. The affected infusion pumps and infusion pump systems lead to over- and under-infusion in patients.
Medtronic is recalling their Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology because there is a risk the device could fracture during use.
Dr. Reddy’s Laboratories Ltd. (along with its subsidiaries together referred to as “Dr. Reddy’s”) announced today that it is voluntarily recalling four lots (ACB902, ACB903, ACB904, ACB905) of Phytonadione Injectable Emulsion USP, 10 mg/mL, Single-Dose Ampules to the hospital level. The product is b
Winter Gardens Quality Foods, Inc., is voluntary recalling one of its products: Whole Foods Market Vodka Sauce carrying the lot code 20057, because of an undeclared allergen (Milk).
Winter Gardens Quality Foods, Inc., is voluntary recalling one of its products: Whole Foods Market Vodka Sauce carrying the lot code 20057, because of an undeclared allergen (Milk).
Tiffany Food Corp. of Brooklyn, NY is recalling Huangfushanzen Huang Mountain Tea Mushroom (黄府山珍茶花菇) Dried Mushrooms with UPC 6 943153 804047 and no other coding, because it may contain undeclared sulfites
FDA is informing health care providers and patients of the potential risk of transmission of SARS-CoV-2 virus by the use of fecal microbiota for transplantation (FMT)
Guan’s Mushroom Co of Commerce, CA is recalling all cases of its 200g/7.05 ounce packages of Enoki Mushroom (Product of Korea) because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail
Recommendations for health care providers and facilities in treating patients who require ventilation assistance due to COVID-19 complications
FDA recognizes that the need for personal protective equipment (PPE), such as medical gloves, may outpace the supply available to health care organizations during the Coronavirus Disease 2019 (COVID-19) outbreak.
Out of an abundance of caution IcelandicPlus LLC of Ft. Washington, PA, is recalling its Capelin Pet Treats because some of the fish have exceeded the FDA compliance guideline for fish larger than 5 inches. The FDA has determined that salt-cured, dried, or fermented un-eviscerated fish larger than 5
Lindt & Sprüngli (USA) Inc. of Stratham, New Hampshire, is issuing a voluntary recall of one lot of its Lindt Excellence 85% Cocoa chocolate bars due to the bars being wrapped in the wrong packaging. The bars are labeled as Excellence 85% Cocoa, but contain Lindt Excellence Dark Caramel Sea Salt bar
Mountain Rose Herbs (MRH) of Eugene, Oregon is recalling all sizes of its Organic Kudzu Root Herbal Supplement from Lot #24247-X and #24247 because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail
CME America, a wholly owned subsidiary of Becton Dickinson, Recalls BodyGuard Microset Infusion Sets Due to Risk of Under-infusion
It has been brought to our attention by the FDA that products containing Red Clover sprouts purchased with the "Best By" dates between 12/1/19 through 3/12/20 may have been contaminated with E. coli0103. At this time no illnesses have been reported
This recall is due to an undeclared wheat allergen in Wegmans branded Ginger Salmon Oven Safe Meal and Salmon Teriyaki Oven Safe Meal, which was manufactured by Raw Seafoods, Inc. for Wegmans. No illnesses or allergic reactions have been reported at this time.
Natural Remedy Store is voluntarily recalling all lots of Active Male, 500mg capsules to the consumer level. FDA analysis has found the product to be tainted with undeclared tadalafil
AFC Distribution Corp. (“AFC”) of Rancho Dominguez, California is voluntary recalling Cooked Butterfly Tail-On Whiteleg Shrimp (Sushi Ebi), Lot #2019.10.02, utilized in various prepared menu offerings with sell-by dates ranging from 02/19/2020 to 03/13/2020, because this ingredient may have a potent
March 13th, 2020, WinCo Foods, LLC. of Boise, ID is recalling frozen Blackberries in a 16 oz. bag and frozen Berry Medley in 16 oz. and 32 oz. bags, manufactured by Rader Farms of Lynden, WA, because both products have the potential to be contaminated with Norovirus. Norovirus is a highly contagiou
FDA is informing health care providers and patients of the potential risk of serious or life-threatening infections with the use of fecal microbiota for transplantation (FMT)
The FDA recognizes that the need for personal protective equipment (PPE), such as surgical masks, surgical and isolation gowns, and surgical suits, may outpace the supply available to healthcare organization during the Coronavirus Disease 2019 (COVID-19) outbreak.
Pero Family Farms Food Company, LLC has initiated a voluntary product recall of its 11oz “Zucchini Spiral Pesto Side Dish Kit” with run number code 1196272F; Use By date of 03/20/2020 due to a product mislabeling which did not declare the allergens of egg and milk.
Advanced Bionics (AB), a global leader in developing advanced cochlear implant systems, announced today that it has begun notifying regulatory authorities that it will voluntarily initiate a field corrective action related to the initial version of HiRes Ultra and Ultra 30 cochlear implant devices
BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today provided an update on a previously announced voluntary recall of the BD Alaris™ System regarding software for the PC Unit and certain modules. BD has notified customers affected by this recall, and the
Sun Hong Foods, Inc 1105 W Olympic Blvd, Montebello, CA 90640 is recalling All Cases Enoki Mushroom (Product of Korea) Net Wt 7.05/200g because it has the potential to be contaminated with Listeria monocytogenes
Meijer is initiating a voluntary recall of 13,284 packages of mixed nuts due to the potential risk of an undeclared tree-nut allergen (Brazil nuts) sold at all Meijer stores, and is being issued to its customers in cooperation with the U.S. Food & Drug Administration.
Recalled due to multiple system errors, software errors, and use-related errors which can lead to delay in infusion, interruption of infusion, slower than expected delivery of medication (under-infusion), and faster than expected delivery of medication (over-infusion).
This recall is due to possible undeclared allergens (peanut, wheat, soy and tree nuts) in H-E-B-branded Tuscan Herb Salad Kit, which was manufactured by Dole for H-E-B. The incorrect masterpack (kit with dressing and other toppings) was unintentionally used during the production of the salad.
Hikma Pharmaceuticals PLC (Hikma, Group), today announces that its subsidiary Hikma Pharmaceuticals USA Inc. (formerly known as West-Ward Pharmaceuticals Corp.; “Hikma”) is voluntarily extending its previously-announced recall of certain lots (listed below) of Ketorolac Tromethamine Injection USP 30
Stonewall Kitchen of York, Maine is voluntarily recalling 4,812 jars of its Ghost Pepper Queso with an Enjoy By date of 23MAY2021, as a small number of those were mislabeled as Ghost Pepper Salsa. Ghost Pepper Queso includes two allergens, milk and soy, that are not included in Ghost Pepper Salsa, a
FDA is strengthening existing warnings about serious behavior and mood-related changes with montelukast (Singulair and generics), which is a prescription medicine for asthma and allergy.
Vita Food Products, Inc. of Chicago, Illinois is notifying the public that it is recalling up to 8,376 individual plastic jars of 32 ounce Vita Wild Herring in Wine Sauce that are potentially mislabeled because they may contain sour cream and, therefore, may contain undeclared milk.
New Capstone, Inc. of Mooresville, NC is recalling their 22oz ReStructure Vanilla Protein Powder pouches, Lot 19211 Exp. 06/21 and their 27 gram individual serving pouch, Lot 19211 Exp. 06/21, because they may contain undeclared milk.
Whole Foods Market is voluntarily recalling select Green Chile Chicken Tamales from stores across 24 states because they contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.
Learn about the SweynTooth cybersecurity vulnerabilities associated with Bluetooth Low Energy (BLE) and recommendations for patients, health care providers, and manufacturers.
Purina Animal Nutrition is initiating a voluntary recall of multiple lots of Purina® Rabbit Feed, Purina® Turkey Feed, Country Acres® Rabbit Feed and DuMOR® Chick Starter/Grower Feed due to elevated calcium levels in the product.
American Health Packaging has voluntarily recalled eleven (11) lots of Ranitidine Tablets, USP 150 mg, 100 count Unit Dose Blisters to the consumer level due to the potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
The device shows an image on the display while examining a patient’s upper airway. A reverse image is displayed which could cause potential injury.
The FDA wants to make consumers and health care providers aware that, to date, the FDA has not authorized for market any products using ozone gas or ultraviolet (UV) light to clean, disinfect, or sanitize continuous positive airway pressure (CPAP) devices and accessories.
Choice Products USA, LLC of Eau Claire, WI, is recalling 275 - 3lb tubs of Peanut Butter Cookie Dough, because it may contain undeclared milk from milk chocolate chips. People who have an allergy or severe sensitivity to milk run the risk of allergic reaction if they consume these products.
The U.S. Food and Drug Administration (FDA) is updating our 2014 safety communication on laparoscopic power morcellators to provide new information on the safe and effective use of laparoscopic power morcellation for gynecologic procedures.
The needle is used to remove air from the lung cavity. If the needle is blocked, emergency treatment is delayed which can lead to heart or lung failure.
FDA reminds health care providers and staff of actions to take to reduce the risk of cardiac surgery infection when using the LivaNova Heater-Cooler System 3T.
Sierra Soups of Fresno, Ca is recalling its 13 ounce packages of "Pasta e Fagioli" because the soup mix contains an individually wrapped package of pasta, which contains gluten
On 11/8/2019, Med Man Distribution voluntarily recalled all lots of Up2 dietary supplement. The recall has expanded to include all lots of dietary supplement Bow and Arrow libido enhancer for men to the consumer level.
Taro Pharmaceuticals U.S.A., Inc. (“Taro” or the “Company”) is voluntarily recalling two (2) lots of Phenytoin Oral Suspension USP, 125 mg/5 mL both in 237 mL bottles, to the consumer level. Phenytoin Oral Suspension USP, 125 mg/5 mL is indicated for the treatment of tonic-clonic (grand mal) and psy
Taro Pharmaceuticals U.S.A., Inc. (“Taro” or the “Company”) is voluntarily recalling two (2) lots of Phenytoin Oral Suspension USP, 125 mg/5 mL both in 237 mL bottles, to the consumer level. Phenytoin Oral Suspension USP, 125 mg/5 mL is indicated for the treatment of tonic-clonic (grand mal) and psy
Moonstruck Chocolate Co. of Portland, Oregon is recalling 1,500 / 3.1 oz. Praline Pecan & Ginger Element Bar in Dark Chocolate, because it may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they
Vitamin Cottage Natural Food Markets, Inc., a Lakewood, Colorado-based natural grocery chain, is recalling Natural Grocers brand 8 ounce Almond Clusters Dark Chocolate Non-GMO because the product contains undeclared peanut allergen. People who have an allergy or severe sensitivity to peanuts run the
. Vitamin Cottage Natural Food Markets, Inc., a Lakewood, Colorado-based natural grocery chain, is recalling Natural Grocers brand 8 ounce Peanut Clusters Dark Chocolate Non-GMO because the product contains undeclared almond allergen. People who have an allergy or severe sensitivity to almonds run
Abbott has voluntarily recalled specific lots of two catheters used in coronary angioplasty procedures: the NC Trek RX Coronary Dilatation Catheter and the NC Traveler Coronary Dilatation Catheter, balloon diameters 4.0mm, 4.5mm and 5.0mm. This recall does not affect patients who have successfully u
Coronary dilation catheters are used to open clogged blood vessels to improve blood flow to the heart, Abbot is recalling these devices due to failure of balloon to deflate in certain models, use may cause serious adverse health consequences, such as reduced blow flow to the heart and air embolism.
The ventilators are used on patients that need breathing support. The sound alarm on the ventilator may fail to alert, presenting a risk of injury or death.
The system provides heated and humidified breathing gases to patients. The system may malfunction causing water to enter the airway causing serious injury.
Saratoga Potato Chips, LLC of Fort Wayne, Indiana is recalling 140 cases of Kroger Sweet & Mesquite BBQ Potato Chips because it may contain undeclared milk
CJ Foods, Inc., a division of CJ America, Inc., of La Palma, CA, is voluntarily recalling Annie Chun’s Japanese-Style Teriyaki Noodle Bowls because it may contain undeclared peanuts. Use of this product may cause serious allergic reaction or illness in people who have an allergy or severe sensitivit
Are recalling approximately 1900 units of the IRISH WHISKEY DARK CHOCOLATE 3.5OZ TABLET BAR because it may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious allergic reaction or illness if they consume these products.
Hubbard Feeds is voluntarily recalling products as the result of an ingredient-supplier recall. The supplied ingredient contained residue of an unapproved herbicide (Haloxyfop).
FDA has requested that the manufacturer voluntarily withdraw the weight-loss drug from the U.S. market because a safety clinical trial shows an increased occurrence of cancer. The drug manufacturer, Eisai Inc,. has submitted a request to voluntarily withdraw the drug.
Save A Lot is recalling 131 cases of Coburn Farms 4.5oz Sharp Yellow Cheddar Cheese, Cherry Juice- Infused Dried Cranberries & Roasted Sea Salted Cashews Snackers due to a labeling error leading to undeclared peanut allergens in Snackers packages manufactured by Great Lakes Cheese Co. Inc., headquar
Missing or broken retainer ring could cause under or over delivery of insulin. This may cause patient injury or death.
McCormick & Company, Inc. is initiating a voluntary recall of Sunny Select Au Jus Gravy Mix 1 oz pouches due to an unlabeled dairy allergen.
Lotte Int’l America Corp is recalling its 11.85-ounce packages of “Chocopie” manufactured by Lotte Confectionery Co. Ltd. Korea because of findings of small amount of almond in the product and packaging shows the “manufactured in a facility that also processes peanut & almond”.
Blendtopia Products, LLC is voluntarily recalling 29,078 cases of 7 ounce frozen Blendtopia brand superfood Smoothie Kits because of potential contamination with Listeria monocytogenes.
Missa Bay LLC of Swedesboro, N.J. is recalling 1,154 cases of Ready PacⓇ BistroⓇ Bowl Spinach Dijon Salad due to a labeling error leading to the potential for undeclared egg and wheat allergens on a limited number of the salads. The salads contain eggs and wheat, which, while visible through the pac
Corinthian Trading, Inc./DBA Corinthian Foods is recalling 5 lb. retail bags of Uncooked Sweet Potato Crusted Alaska Pollack Nuggets 1 oz. with date code CF35319 due to mislabeling. The bag contains Chicken Nuggets instead of Fish Nuggets. The product is packaged in clear 5 lb. bags with a white
Nuts ‘N More of East Providence, RI. is recalling 4143 jars of plain Peanut Spread because it has the potential to be contaminated with Listeria species and to protect the public from a potential health hazard.
A loose cable connection could cause the loss of mechanical ventilation which could lead to serious injury or death.
This product is being voluntarily recalled due to the presence of an undeclared allergen (soy). Customers who purchased this product and are allergic to soy are urged to not consume it.
Cargill’s animal nutrition business is conducting a voluntary recall of a single lot (382 bags, 50 lb each) of NutreBeef® Transition Pellet (MH) beef cattle feed because the product may contain mispackaged feed with elevated levels of monensin
Whole Foods Market is voluntarily recalling select bundt cakes and chocolate dipped cookies from stores in Kentucky, Maryland, New Jersey, Pennsylvania, Ohio, Virginia and Washington D.C. because they contain undeclared milk.
People who have an allergy or severe sensitivity to milk run the risk of
A manufacturing problem could cause the displayed oxygen values to be incorrect which could lead to serious injury or death.
Nopalina Flax Seed Fiber (powder) and Nopalina Flax Seed Fiber (capsule) products due to possible Salmonella contamination in one of the ingredients used on the formula of Nopalina Flax Seed Fiber.
Efficient Laboratories, Inc. is voluntarily recalling one lot each of Rompe Pecho EX, Rompe Pecho CF, and Rompe Pecho MAXliquid. Specifically, we are recalling the following lots: Rompe Pecho EX lot 19F332, exp June 2022, Rompe Pecho CF lot 19H359, exp August 2022 and Rompe Pecho MAX lot 19B42, ex
Regarding cybersecurity vulnerabilities identified in a wireless telemetry technology used for communication between Medtronic’s implantable cardiac devices, clinic programmers, and home monitors.
Bakkavor Foods USA, Inc. is voluntarily recalling 840 units of Harris Teeter’s Fresh Food Market Mushroom Barley Soup, 16 oz with “SELL BY” date codes 03/09/20 because it may contain undeclared milk.
Beepa’s of Beloit, WI is recalling Goulash, because it may contain undeclared milk
FDA is strengthening an existing warning that constipation caused by the schizophrenia medicine clozapine (Clozaril, Fazaclo ODT, Versacloz, generics) can, uncommonly, progress to serious bowel complications. This can lead to hospitalization or even death if constipation is not diagnosed/treated.
Salud Natural Entrepreneur, Inc. of Waukegan, IL is voluntarily recalling Nopalina Flax Seed Fiber (powder) and Nopalina Flax Seed Fiber (capsule) products due to possible Salmonella contamination
The Babi.Plus Pressure Relief Manifold is used as part of a breathing circuit to assist infant patients to breathe. This device is being recalled due to a dislodged valve resulting in loss of pressure in the system. Teleflex issued a Medical Device Recall Notice to affected customers.
Quesos La Ricura LTD. of Hicksville, NY, is recalling 12 oz. packages of Cotija Cheese (Queso Cotija) because it may be contaminated with Shiga toxin producing E. coli bacteria (Shiga toxin producing E. coli).
King Systems initiated a voluntary recall of One-Hundred Seventy-One (171) units of its King Vision Video Laryngoscope Adapter Size 1/2. The affected products have been found to exhibit a reversed image, which could potentially result in difficulty navigating during intubation and/or delay in intub
The FDA posts Medical Device Safety Communications to describe the FDA's current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient management.
FDA is informing health care providers and facility staff about cybersecurity vulnerabilities that may introduce risks to patients while being monitored using certain GE Healthcare Clinical Information Central Stations and Telemetry Servers.
Lipari Foods is expanding its January 6, 2020 and January 13, 2020 recalls of Premo and Fresh Grab sandwiches to include all sandwiches with a Best By date of 2/6/20 and prior, due to potential contamination of Listeria monocytogenes
This recall applies to all dietary supplement products manufactured and sold between January 2013 – November 2019 and all lots of products are included in this recall. These products are being recalled after an FDA inspection found significant violations of current good manufacturing practice regula
Five Star Food Inc, Garden City, MI is recalling 100 cases of Excellent tahina 800 g and 100 cases of excellent tahina 400 g containers because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or eld
Products that contained frozen diced eggs from Almark Foods have the potential to be contaminated with Listeria monocytogenes
Yes To Inc. has issued a voluntary recall of all lots of its Grapefruit Vitamin C Glow-Boosting Unicorn Paper Mask in response to complaints of skin irritation and redness.
The medical device manufacturer Cardinal Health alerted its customers to potential quality issues affecting some of its Level 3 surgical gowns and accompanying PreSource procedural packs.
FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutical is voluntarily recalling all unused sterile drug products within expiry, to the user level, due to a lack of assurance of sterility. The recalled sterile products have been found to be inconsistent with federal guidelines.
FDA is sharing recommendations and updates to help improve duodenoscope reprocessing.
FDA is alerting the public that results from a clinical trial assessing safety show a possible increased risk of cancer with the weight management medicine Belviq, Belviq XR (lorcaserin).
Lipari Foods has issued a voluntary recall of various Premo and Fresh Grab wedge sandwiches due to potential contamination of Listeria monocytogenes.
Lipari Foods has issued a voluntary recall expansion of additional Premo and Fresh Grab sandwiches due to potential contamination of Listeria monocytogenes.
Taro Pharmaceuticals U.S.A., Inc. (“Taro” or the “Company”) is voluntarily recalling one (1) lot of Lamotrigine 100 mg Tablets, Lot # 331771 (expiration date June 2021) in 100 count bottles, NDC 51672-4131-1 to the consumer level.
Stryker announced today that the company is launching a voluntary field action on specific units of the LIFEPAK 15 monitor/defibrillators.
Protein Snack Tray 6.44 oz total weight packaged in a 4-compartment plastic tray with UPC: 8-5511000804-6 and with Fresh by lot dates of: 12/21/19, 12/22/19, 12/24/19, 12/27/19, 12/28/19, 12/29/19, 12/31/19, 01/03/20, 01/04/20. Protein Trail Mix 3.52 oz total weight packaged in a 10.5 ounce pla
Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall, to the consumer level, of three lots of Nizatidine Capsules, USP (including the 150mg and 300mg strengths). While Mylan has not received any reports of adverse eve
Denton Pharma, Inc. dba Northwind Pharmaceuticals, an affiliate of Northwind Pharmaceuticals, LLC (“Northwind”) today announced the voluntary recall of all unexpired lots of Ranitidine Tablets, 150 mg and 300mg, to the consumer level. The recall is in response to the manufacturer’s recall of all un
Mavidon is voluntarily recalling all lots of products manufactured at our facility including LemonPrep®, PediaPrep® and Wave Prep 4-ounce tubes and single use cups, Cardio Prep and Collodions, Collodion removers due to contamination with Burkholderia cepacia.
Jeni’s Splendid Ice Creams has initiated a voluntary recall of three batches of Cold Brew with Coconut Cream Non-Dairy Frozen Dessert pints because they may contain an undeclared milk allergen
Appco Pharma LLC (Appco) is voluntarily recalling all quantities and lots, within expiry, of Ranitidine Hydrochloride Capsules to the Consumer level. Ranitidine Hydrochloride Capsules are being recalled because of the presence or potential presence of N-nitrosodimethylamine (NDMA)
Purely Elizabeth is initiating a voluntary recall of their Chocolate Sea Salt Probiotic granola due to a mislabeling error that has resulted in an undeclared allergen (walnuts) being present.
Ducktrap River of Maine of Belfast, Maine is announcing a voluntary recall of Herring Center Cuts in Wine Sauce identified with sell by date Jul 29, 2020 because these products contain undeclared milk due to an incorrect label.
Cargill is voluntarily recalling 39 one-pound bags of product incorrectly packaged as Wilbur Dark Chocolate Covered Cashews. Sold locally through the Wilbur Chocolate Store in Lititz, Penn., the bags are being recalled out of an abundance of caution because of a wheat allergen presence. Wilbur Dark
Limena, LLC of Palm Springs, FL. is recalling its 1 lb. (16 ounce) blocks of Salvadorean String Cheese (Quesillo Cheese) semi-soft cheese because it has the potential to be contaminated with Listeria monocytogenes
FiveStar Gourmet Foods takes issues of food safety seriously and in an abundance of caution is voluntarily recalling two fresh produce snack products, MiniMeal2Go-ProteinPack 8.25oz and MiniMeal2Go- AvocadoToast 6.75oz. due to the notification from Almark Foods of Gainesville, GA that Almark Foods m
Dianne's Fine Desserts of Newburyport, MA 01950 is recalling twenty six cases of product Sienna Turtle Brownie 8495241115 lot code 19198 , because it may contain undeclared peanuts. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reac
As part of a multi-state recall due to the potential risk of Listeria monocytogenes, Meijer – in conjunction with Almark Foods - is announcing a voluntary recall of frozen hard-boiled egg products used on two salad bars at two stores in Grand Rapids, Mich.
Aurobindo Pharma USA, Inc. is voluntarily recalling lot number 03119002A3 of Mirtazapine Tablets to the consumer level. The product is being recalled due to a label error on declared strength; bottles labeled as Mirtazapine 7.5 mg may contain 15 mg tablets.
Veggie Noodle Co., LLC is voluntarily recalling its Cece’s® Veggie Co. brand Fresh Veggie Ramen with Chicken Broth, all expiration dates, sold at retail stores nationally, because the separately packaged egg that is included in the product has the potential to be contaminated with Listeria
Sprouts Unlimited of Marion IA is recalling clover spouts in 4 oz packages because it may be contaminated with Escherichia coli O103 bacteria
Great American Deli of Ooltewah, Tennessee is recalling GAD #114 Egg Salad Sandwich 4.8 oz. UPC: 7-41431-00114-2 due to possible contamination of Listeria monocytogenes
Out of an abundance of caution, Reichel Foods Inc. is voluntarily recalling Pro2Snax To The Max Granny Apples /Hard Boiled Egg/Cheddar/Cashew & Craisin and Pro2Snax To The Max Gala Apples/Hard Boiled Egg/White Cheddar/Almond & Craisin.
Due to a recent recall by Almark, an ingredient supplier, and out of an abundance of caution for safety of our customers St. Louis based Dierbergs Markets is recalling various products in all 25 retail stores.
Almark Foods is expanding its voluntary recall to include all hard-boiled eggs manufactured at the firm’s Gainesville, Georgia facility, including all retail, pillow pack, pouch pack, frozen diced, and protein kit products, , due to potential contamination with Listeria monocytogenes.
Bakkavor Foods USA, Inc. is voluntarily recalling Trader Joe’s Egg Salad, 6 oz and Trader Joe’s Old Fashioned Potato Salad, 20 oz with “USE BY” date codes up through and including 12/27/19 because these products have the potential to be contaminated with Listeria monocytogenes.
Mavidon is voluntarily recalling all lots of products manufactured at our facility including LemonPrep®, PediaPrep® and Wave Prep 4-ounce tubes and single use cups, Cardio Prep and Collodions, Collodion removers due to contamination with Burkholderia cepacia.
Almark Foods is voluntary recalling Hard-Boiled and Peeled Eggs in white plastic pails with white plastic lids due to the potential to be contaminated with Listeria monocytogenes. Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or
Emesa Foods, Taylor, MI is voluntarily recalling 23 cases and each case 6 containers of 800 gram of “Premium Sesame Tahini” because it has the potential to be contaminated with Salmonella.
Whole Foods Market is voluntarily recalling 365 Everyday Value Dark Chocolate Peppermint Sandwich Cremes and 365 Everyday Value Dark Chocolate Caramel Sea Salt Sandwich Cremes because the products may contain undeclared milk or tree nuts (coconut).
LivaNova is recalling the VNS Therapy SenTiva Generator System due to an unintended reset error that causes the system to stop delivering VNS therapy.
FDA is warning that serious breathing difficulties may occur in patients using gabapentin or pregabalin who have respiratory risk factors.
The software updates could cause alarms to stop working and cause the battery to drain without warning and potentially interrupt therapy, which could lead to serious injury or death.
Lannett Company, Inc. today announced that it is voluntarily recalling two (2) lots of Levetiracetam Oral Solution, 100mg/mL to the consumer level due to contamination with Bacillus subtilis. The Bacillus subtilis was identified during an evaluation of a raw material used to manufacture the product
The bedside panels and portholes can appear closed without being latched, no longer protect the infant from falling.
Motto International Corp. is voluntarily recalling all lots of Bull Platinum 30000, Stallion Platinum 30000, Rhino 7 Platinum 30000, and Panther Platinum 30000, to the consumer level.
FDA classifies Class I recall for Cook Medical CrossCath® Support Catheters due to radiopaque marker bands being too loose or too tight on certain catheters.
Glenmark Pharmaceutical Inc., USA (“Glenmark”) today announced the voluntary recall of all unexpired lots of Ranitidine Tablets, 150 mg and 300 mg, to the consumer level.
Medtronic received reports of early permanent motor stall due to the presence of foreign particles. Permanent motor stall could lead to serious injury or death.
CATSMO LLC. Of Wallkill, NY, out of an abundance of caution, is recalling Cold Smoked Salmon because it has the potential to be contaminated with Listeria monocytogenes.
“This recall has been initiated due to possible Salmonella contamination, which poses a health risk. It is important to know that no illnesses have been reported, and the amount of affected product is minimal.
FDA is informing the public, especially patients, health care practitioners, and clinics, of multiple recent reports of serious adverse events experienced by patients in Nebraska who were treated with unapproved products marketed as containing exosomes.
FDA is informing the public, especially patients, health care practitioners, and clinics, of multiple recent reports of serious adverse events experienced by patients in Nebraska who were treated with unapproved products marketed as containing exosomes.
Tailor Cut Produce of New Jersey, is recalling its Fruit luau, cut honeydew, cut cantaloupe and cut pineapple products because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people.
Charlotte headquartered Tropical Nut and Fruit Co. is voluntarily recalling their 25lb box of Truly Good Foods South of the Border nut mix, Lot #29119, best by date 04/15/2020, item # 102340 and UPC # 094184110198 because it contains undeclared soy and tree nut (al-monds).
White Castle has initiated a voluntary recall of a limited number of frozen 6 pack cheeseburgers, frozen 6 pack hamburgers, frozen 6 pack jalapeno cheeseburgers, and 16 pack hamburgers, 16 pack cheeseburgers for the possible presence of Listeria monocytogenes.
The J. M. Smucker Company today announced a voluntary recall of specific lots of Special Kitty® wet, canned cat food due to health concerns potentially associated with ingredients believed to not meet the Company’s quality and safety standards.
Nassau Candy Distributors of Hicksville, NY is recalling two lots of 7.5 OZ (212g) Nancy Adams, Dark Chocolate Graham Crackers because they may contain undeclared milk allergens.
Dole Fresh Vegetables, Inc. is voluntarily recalling a limited number of cases of Colorful Coleslaw.
Lin’s Waha Int’l Corp of Syosset, NY is recalling its 8.11 OZ (230G) packages of Suantianyangmei Waxberry and Bingtangyangmei Waxberry because they contain undeclared sulfites and cyclamates.
Fuji Food Products, Inc. (Fuji) announced today the voluntary recall of ready to eat sushi, salads and spring rolls sold to select retailers and distributors along the East Coast and Upper Midwest.
The FDA is providing the most recent, interim post-approval study results for Abiomed's Impella RP System.
UNFI announced today a voluntary national recall of five-pound bags of its Wild Harvest® Organic All-Purpose Flour, Unbleached
Hodgson Mill of Effingham, IL, announced today a voluntary national recall of specific lots of its Unbleached All-Purpose White Wheat Flour (5 lb.)
B. Braun Medical Inc. [B. Braun] initiated a voluntary recall of twenty-two (22) lots of Blood Administration Sets. B. Braun identified through complaints and internal discrepancies the potential for leakage at the joint between the blood filters and tubing of these blood administration sets.
Northern Fisheries LTD of Little Compton, RI, has expanded their voluntary recall of frozen, wild-caught yellowfin Tuna Medallions (product of Vietnam) to include product sold directly to consumers. This recall is due to potentially elevated levels of histamine.
Whole Foods Market is voluntarily recalling one lot code of Whole Foods Market Raspberry Cheesecake Italian Gelato because these product units contain egg that is not listed on the product label. People who have an allergy or severe sensitivity to egg run the risk of serious or life-threatening alle
“Euroline Foods LLC” of Staten Island, NY is recalling its 17.65oz (500 gram) packages of “DRY FRUIT MIX “QUINCE COMPOTE” ” because they contain undeclared sulfites. Consumers who have severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this
Mondelēz Global LLC announced today a voluntary recall of a limited quantity of Cheese Nips (11 oz. Box) product in the United States due to the potential presence of small food-grade yellow plastic pieces from a dough scraper that was incorporated into the production process of a small amount of pr
Precision Dose Inc. is voluntarily recalling 5 lots of Ranitidine Oral Solution, USP 150 mg/10 mL to the consumer level. Ranitidine Oral Solution, USP 150 mg/10 mL, is being recalled because of potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
The U.S. Food and Drug Administration (FDA) is providing an update on our evaluation of device failures associated with Getinge's Maquet/Datascope intra-aortic balloon pump (IABP) devices: Cardiosave (Hybrid and Rescue), CS300 and CS100/CS100i.
The FDA is evaluating recent reports of Getinge's Maquet/Datascope intra-aortic balloon pump (IABP) devices shutting down while running on battery power.
Select varieties of Breakstone’s Cottage Cheese are voluntarily being recalled due to the potential presence of pieces of red plastic and metal that may have been introduced during production.
Go Raw, LLC, of Cottonwood Utah is recalling its 2lb. frozen bags of “Quest Beef Cat Food” because they may be contaminated with Salmonella.
The remote controllers of some Medtronic MiniMed insulin pumps are vulnerable to cybersecurity risks. Unauthorized persons could record and replay the wireless communication from the remote to the MiniMed insulin pump leading to the administration of one ore more unintended boluses of insulin.
The detector on the Forte Gamma Camera System has the potential to drop without warning which could result in a serious injury or death.
Zimmer Biomet recalled the ROSA Brain Device due to a software issue which can drive the robotic arm to an incorrect position resulting in risks for the patient.
Golden State Medical Supply, Incorporated (GSMS, Inc) based upon a manufacturer’s recall by Novitium Pharma LLC (Novitium), is voluntarily instituting a recall of all quantities and lots, within expiry, of Ranitidine HCl 150mg and 300mg Capsules to the consumer level because of potential presence of
CHS Inc., based in Inver Grove Heights, Minnesota, is voluntarily recalling 67 tons of Payback® Feeds listed below due to potentially high levels of magnesium.
Vitamin Cottage Natural Food Markets, Inc., a Lakewood, Colorado-based natural grocery chain, is recalling Natural Grocers brand 2-pound Organic Soybeans because they have the potential to contain mold. Consumers who may have purchased this product are advised to discontinue use and either throw it
Voluntarily recalling Marketside Brand Creamy Cauliflower Parmesan Soup 16oz because a limited quantity of retail pots may contain Fish and Wheat allergens not declared on the label.
Nature’s Rx is voluntarily recalling lot: 01251ZX1, Expiry Date: 11/2022 of Silver Bullet (10 Male Enhancement Capsules). This recall has been initiated after an FDA laboratory analysis found the product to contain undeclared sildenafil, the active ingredient in Viagra, which is a PDE-5 inhibitor.
Taher, Inc., in conjunction with Mann Packing Co., as part of a multi-state recall due to the potential risk of Listeria monocytogenes, in an abundance of caution is announcing a voluntary recall of vegetable cups served in select locations in Minnesota.
Amneal Pharmaceuticals, LLC. Bridgewater, New Jersey is voluntarily recalling Ranitidine Tablets, 150 mg and 300 mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL to the consumer level. A listing of the recalled lots is identified below.
Ranitidine Tablets, USP, 150 mg and 300 mg
Russ Davis Wholesale (RDW), a leading fresh produce processor and distributor, in an abundance of caution is voluntarily recalling multiple products due to possible contamination of Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or
The voluntary recall is a response to a notification by the Food and Drug Administration and the Canadian Food Inspection Agency of a potential contamination with Listeria monocytogenes.
In response to Mann Packing Co., Inc’s recall of vegetable products, Whole Foods Market is voluntarily recalling multiple products from its stores in the United States. Mann Packing issued the recall because the vegetables may be contaminated with Listeria monocytogenes. No illnesses have been repor
Med Man Distribution is voluntarily recalling all lots of Up2 Dietary supplement There is no other all-natural libido for men and women to the consumer level.
American Health Packaging is voluntarily recalling eight lots of Ranitidine Syrup (Ranitidine Oral Solution USP) 150 mg/10 mL Liquid Unit Dose Cups to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the f
Peekay International Inc. 56 12 56th Street, Maspeth, NY is recalling its 7 ounce and 14 ounce packages of “SWAN DRY YELLOW DATES” and “KESHAV DRY YELLOW DATES” food treats because they contained undeclared sulfites.
Mill Stream Corp. (Sullivan Harbor Farm) of Hancock, Maine is voluntarily recalling ten lots of Cold Smoked Salmon because it has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product
Aurobindo Pharma USA, Inc. is conducting a voluntary recall of 1 lot of Ranitidine Tablets 150mg to the retail level and 37 lots of Ranitidine Capsules 150mg, Ranitidine Capsules 300mg and Ranitidine Syrup 15mg/mL to the consumer level due to the detection of NDMA (Nitrosodimethylamine) Impurity in
Abbott is recalling their CentriMag System due to a calibration system error resulting from electromagnetic interference (EMI) that may cause low or no flow from the device, the console screen to blank, and various inaccurate alarms.
The U.S. Food and Drug Administration (FDA) is updating our 2017 safety communication.
The FDA is alerting the public, health care providers, lab personnel, and lab test developers that biotin can significantly interfere with certain lab tests and cause incorrect test results which may go undetected.
Voluntarily Recalling all unexpired lots of LETS GEL KIT Convenience Packs to the hospital, pharmacy and distributor level. The product has been found to potentially contain microbial contamination in the non-sterile Suturagel Methylcellulose base component of the LETS GEL KIT Convenience Packs.
Wawona Frozen Foods is voluntarily recalling packages of frozen raspberries and frozen berry mixes containing raspberries sold at Aldi Grocery Stores and frozen raspberries sold at Raley's Family of Fine Stores because they have the potential to be contaminated with Hepatitis A.
ICU Medical, Inc. (Nasdaq: ICUI) is voluntarily recalling one single lot of Lactated Ringer's Injection, USP, and one single lot of 0.9% Sodium Chloride Injection, USP. The products are being recalled to the hospital level due to the presence of particulate matter.
Some ECHELON FLEX ENDOPATH staplers may contain an out of specification component, which may cause malformed staples, which may cause patient injury or death.
Golden Dragon Fortune Cookies Inc., of Chicago, Illinois is recalling Golden Dragon Inc. Chinese Almond Cookies, because it may contain undeclared Milk.
North Bay Produce, Inc. of Traverse City, Michigan is voluntarily recalling 2,297 cases and 2 bulk bins of fresh apples due to the potential to be contaminated with Listeria monocytogenes.
The FDA is evaluating new information about the risk of blood continuing to leak into the aneurysm (Type III endoleak) with Endologix AFX.
Mylan Pharmaceuticals Inc. is conducting a voluntary nationwide recall of one lot (see table below) of Alprazolam Tablets, USP C-IV 0.5 mg, to the consumer/user level. This lot is being recalled due to the potential presence of foreign substance
Voluntarily recalling all quantities and lots, within expiry, of Ranitidine Hydrochloride Capsules in the US to the consumer level. Ranitidine Hydrochloride Capsules are being recalled because of potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
Lannett Company, Inc. today announced that it is voluntarily recalling all lots within expiry of Ranitidine Syrup
Peekay International Inc. 56 12 56th Street, Maspeth, NY is recalling its 7 ounce and 14 ounce packages of “SWAN DRY APRICOT” and “KESHAV DRY APRICOT” food treats because they contained undeclared sulfites. Consumers who have severe sensitivity to sulfites run the risk of serious or life-threatening
Shivam Distributors of Longwood, FL is recalling its 7 ounce and 14 ounce packages of PARIVAR brand Dry Dates with batch # 125/BIBT because they contain high sulfite content, a preservative which could cause adverse health consequences with symptoms such as itchiness, upset stomach, headache.
As a precautionary measure, Sanofi on Friday, October 18, intiated a voluntary recall of all Zantac OTC (over-the-counter) in the United States. This includes Zantac 150®, Zantac 150® Cool Mint, and Zantac 75®.
As a precautionary measure, Perrigo Company plc announced today that it has initiated a voluntary, worldwide product recall to the retail customer level of ranitidine (all pack sizes). The recall is being taken due to possible presence of a nitrosamine impurity called N-nitrosodimethylamine (NDMA).
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
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.
Johnson & Johnson Consumer Inc. (JJCI) announced that it is initiating a voluntary recall in the United States of a single lot of its Johnson’s Baby Powder in response to a U.S. Food and Drug Administration (FDA) test indicating the presence of sub-trace levels of chrysotile asbestos contamination.
Peekay International Inc. 56 12 56th Street, Maspeth, NY is recalling its 7 ounce and 14 ounce packages of “KESHAV Dry Apricot” food treats because they contained undeclared sulfites.
2019 Biologics Recalls
| Date Notification | Brand Name | Product DescriptionImportant Drug Information - Humate-P [Antihemophilic Factor/von Willebrand Factor Complex (Human)]10/16/2019 Medical RecallCSL Behring LLC is alerting customers to a misalignment in the printing of the data on the folding box of Humate-P that might lead to confusion of the user. Mical Seafood Inc Recalls Tuna Products for Possible Scombroid Poisoning10/15/2019 Food RecallVoluntarily initiated a recall of frozen, wild-caught yellowfin tuna poke cubes, tuna loins, tuna ground meat and 6oz tuna steaks because of potentially elevated levels of histamine. Elevated levels of histamines can produce an allergic reaction called scombroid fish poisoning. Mical Seafood Inc. Voluntarily Expands Tuna Recall for Possible Scombroid Poisoning10/15/2019 Food RecallMical Seafood, Inc. of Cooper City, FL, has voluntarily initiated an expanded recall of frozen, wild-caught yellowfin Tuna Loins, Tuna Poke, Tuna Steaks, Tuna Ground Meat, and Tuna Saku (products of Vietnam) due to potentially elevated levels of histamine. Samurai, Inc. Issues Allergy Alert On Undeclared Fish In Furikake Popcorn 5oz. Package10/15/2019 Food RecallSamurai, Inc. of Honolulu, Hawaii is conducting a voluntary recall on 16,660 packages of Furikake Popcorn, because it may contain undeclared Fish. People who have an allergy or severe sensitivity to fish run the risk of serious or life-threatening allergic reaction if they consume these products. Viatrexx Bio Incorporated Issues Voluntary Nationwide Recall of Sterile Injectables due to a Lack of Sterility Assurance10/15/2019 Medical RecallViatrexx Bio Incorporated, Newark, Delaware is voluntarily recalling 10 mL sterile injectable vials of products, listed in the table below with lot numbers, to the consumer level. The products were sold exclusively to practitioners for office use. The products were manufactured in a manner that cann Update: Recall of Frozen Cookie Dough Products Due to Allergen Health Risk is Expanded to Include Additional Lot Codes10/11/2019 Food RecallCalifornia New Foods has expanded its voluntary recall of frozen cookie dough products due to a lack of labeling that addresses the potential for the products to contain peanut and walnut allergens. Fisherman’s Pride Processors Issues Recall of Shrimp Product Due to Misbranding and Undeclared Milk and Soy Allergens10/10/2019 Food RecallFisherman’s Pride Processors Inc. of Vernon, CA is recalling 100 bags of Schwan’s Brand “Garlic Herb Shrimp” with date code 4A924608xx-B1 due to undeclared milk and soy. UNFI Voluntarily Recalls Arla Apetina Marinated Feta & Olives in Oil, Pitted Because of Possible Health Risk10/10/2019 Food RecallThe product requires refrigeration to ensure food safety and we have learned that some product distributed to retail customers from 2 UNFI distribution centers may have been exposed to temperatures above refrigeration during storage and/or distribution by UNFI’S customers. Jumbo Foods Inc. Recalls Frozen & Fresh Chicken Salad Sandwiches Because of Possible Health Risk10/10/2019 Food RecallJumbo Foods Inc. of Mukilteo, WA has issued a voluntary recall of Tuscan Sun (TS) brand chicken salad sandwiches, because it has the potential to be contaminated with Listeria monocytogenes Allergy Alert for Undeclared Milk & Egg In White Parkerhouse Rolls Issued by Four Whole Foods Market Stores in Midwest10/10/2019 Food RecallFour Whole Foods Market stores in the Midwest region are voluntarily recalling White Parkerhouse Rolls because they may contain undeclared milk and egg. Innoveix Pharmaceuticals, Inc. Issues Voluntary Recall of all Sterile Compounded Drug Products Due to a Lack of Sterility Assurance10/10/2019 Medical RecallInnoveix Pharmaceuticals, Inc. is voluntarily recalling all sterile compounded drug products, within expiry, to the consumer level. The products are being recalled due to a lack of assurance of sterility. These concerns arose following a routine inspection of the pharmacy by FDA. Blue Bell Ice Cream Recalls a Select Lot of Butter Crunch Half Gallons for Possible Foreign Object10/09/2019 Food RecallBlue Bell Ice Cream is voluntarily recalling a select lot of half gallon Butter Crunch Ice Cream produced on a specific line on August 26, 2019 in its Sylacauga, AL plant because of the possibility the products may contain a foreign object. Lipari Foods Issues Recall of Bulk Chicken Salads and Chicken Salad Sandwiches Due to Potential Contamination of Listeria Monocytogenes10/08/2019 Food RecallVoluntary recall of Lipari Old Tyme Bulk Chicken Salad, Lipari Old Tyme Bulk Cranberry Almond Chicken Salad, Premo Chicken Salad Wedge Sandwiches, Fresh Grab Chicken Salad Wedge Sandwiches, and Premo Signature Cranberry Almond Chicken Salad on Croissant due to Listeria monocytogenes Lipari Foods Issues Recall of Ham & Cheese Wedge Sandwiches Due to Potential Contamination of Listeria Monocytogenes10/08/2019 Food RecallLipari Foods has issued a voluntary recall of Premo Ham & Cheese Wedge Sandwiches and Fresh Grab Ham & Cheese Wedge Sandwiches due to potential contamination of Listeria monocytogenes 2019 Medical Device Recalls10/08/2019 Medical RecallThe 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 Filters10/08/2019 Medical RecallICU Medical, Inc. announced a voluntary recall on 29 July 2019 of certain lots of Plum and Sapphire Microbore Infusion Sets with inline filters due to the potential for small amounts of fluid leaking out of the air vents on the inline filters. To date, ICU Medical is not aware of adverse events rela Medtronic Recalls 6 French Sherpa NX Active Guide Catheters Due to Separation and Fragmentation Issue10/08/2019 Medical RecallMedtronic is recalling the 6 French Sherpa NX Active Guide Catheter due to a risk of the outer material separating from the device resulting in detached fragments that could result in the underlying stainless-steel braid wires being exposed. ADM Animal Nutrition Recalls MoorMan’s® ShowTec® Lamb Creep DC10/04/2019 Food RecallADM Animal Nutrition, a division of Archer Daniels Midland Company (NYSE: ADM), is voluntarily recalling 50-pound bags of MoorMan’s® ShowTec® Lamb Creep DC, product number 11153AE, because the product may contain high levels of copper. The J. M. Smucker Company Issues Voluntary Recall of Specific Lots of Robin Hood® All Purpose Flour Distributed and Sold in the U.S. Only10/04/2019 Food Recall
Out of an abundance of caution, The J. M. Smucker Company today announced a voluntary recall of specific lots of Robin Hood® All Purpose Flour distributed and sold in the U.S. due to possible E. coli contamination. This recall does not impact any Robin Hood® items sold in Canada. Lung Injury Update: FDA Warns Public to Stop Using Tetrahydrocannabinol (THC)-Containing Vaping Products and Any Vaping Products Obtained Off the Street10/04/2019 Medical RecallFDA is strengthening its warning to consumers to stop using vaping products containing THC amid more than 1,000 reports of lung injuries—including some resulting in deaths—following the use of vaping products. Coborn’s, Inc. Issues Recall of Select Chicken Salad Products Due to Possible Listeria Contamination10/04/2019 Food RecallCoborn's, Inc. is recalling select chicken salad products, which may have been contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. 2019 Safety Communications10/01/2019 Medical RecallThe FDA posts Medical Device Safety Communications to describe the FDA's current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient management. URGENT/11 Cybersecurity Vulnerabilities in a Widely-Used Third-Party Software Component May Introduce Risks During Use of Certain Medical Devices: FDA Safety Communication10/01/2019 Medical RecallURGENT/11 Cybersecurity Vulnerabilities in a Widely-Used Third-Party Software Component May Introduce Risks During Use of Certain Medical Devices: FDA Safety Communication Dorset Cheese Voluntarily Recalled by North Atlantic and Northeast Whole Foods Market Stores Due to Possible Health Risk09/30/2019 Food RecallIn response to a recall from Consider Bardwell Farm, Whole Foods Market stores in the Northeast and North Atlantic regions are voluntarily recalling Dorset cheese because of a potential contamination of Listeria monocytogenes Cellect Products Inc. and Oglethorpe Ltd. Issue Voluntary Worldwide Recall of Cellect Unflavored Powder & Essentials Factor Cell Synergy Unflavored Powder, Lot #041907 Due to Potential Unsafe Levels of Arsenic and Lead09/30/2019 Food RecallThe Cellect Unflavored Powder & Essentials Factor Cell Synergy Unflavored Powder has been found to have unsafe levels of Arsenic and Lead. Consider Bardwell Farm Recalls Dorset, Slyboro, and Experience Because of Possible Health Risk09/30/2019 Food RecallThese products may be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people and others with weakened immune systems. Healthy individuals may suffer only short-term symptoms such as high fever, severe he Mavidon Issues Voluntary Worldwide Recall of LemonPrep® Tubes and Single use cups09/30/2019 Food RecallMavidon is voluntarily recalling 21 lots of LemonPrep® 4 ounce tubes and single use cups to user level. These products have been found to be contaminated with Burkholderia cepacia. The specific lots are listed below: Rong Shing Trading Ny Inc. Issues Allergy Alert on Undeclared Milk in Ganchi Naiweitangpian Candies09/27/2019 Food RecallRONG SHING NY Trading Inc. of Brooklyn, NY, is recalling its 280-gram (9.8-ounce) packages of GANCHI NAIWEITANGPIAN candy because they may contain undeclared milk allergen. Consumers who are allergic to milk may run the risk of serious or life-threatening allergic reactions if they consume this prod Keurig Dr Pepper Announces Voluntary Withdrawal of Unflavored Peñafiel Mineral Spring Water that Does Not Meet FDA Bottled Water Quality Standards09/26/2019 Food RecallKeurig Dr Pepper today announced it will voluntarily withdraw Peñafiel unflavored mineral spring water products, imported from Mexico, due to the presence of violative levels of arsenic. Apotex Corp. Issues Voluntary Nationwide Recall of Ranitidine Tablets 75mg and 150mg (All pack sizes and Formats) due to the potential for Detection of an Amount of Unexpected Impurity,N-nitrosodimethylamine (NDMA) Impurity in the product09/25/2019 Food RecallApotex Corp. is voluntarily, on a precautionary basis, recalling Ranitidine Tablets 75mg and 150mg (All pack sizes and Formats) to the Retail level. Apotex has learned from the U.S. Food and Drug Administration and other Global regulators that some ranitidine medicines including brand and generic fo Weaver Fundraising, Llc Issues Allergy Alert on Undeclared Almonds, Cashews, and Pecans in Trail’s End Chocolatey Caramel Crunch Sold in Houston and Corpus Christi, Texas09/25/2019 Food RecallWeaver Fundraising, LLC (Indianapolis, IN) is voluntarily recalling 15 oz. tins containing Trail’s End Chocolatey Caramel Crunch because they may inadvertently contain almonds, cashews and pecans. B. Braun Medical Inc. Issues Voluntary Nationwide Recall of one lot of one catalog item number of an Infusomat® Space Volumetric Infusion Pump Administration Set, Due to Potential Leakage09/24/2019 Food RecallB. Braun Medical Inc. [B. Braun] initiated a voluntary recall of one lot of Infusomat® Space Volumetric Infusion Pump Administration Sets (Catalog Number 363032, Lot Number 0061641410). The recalled administration sets are used to deliver parenteral fluids. B. Braun identified through customer compl Euphoria Fancy Food Inc. Recalls “Capitan K Salmon Fillet” Due to Possible Health Risk09/24/2019 Food RecallEuphoria Fancy Food Inc of Brooklyn, NY is recalling its 7.05 oz packages of “CAPITAN K” salmon slightly salted pieces because they may be contaminated with Listeria monocytogenes. Sandoz Inc. Issues Voluntary Recall of Ranitidine Hydrochloride Capsules 150mg and 300mg Due to An Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA), in the Product09/24/2019 Food Recall– Sandoz Inc. is voluntarily recalling all quantities and lots within expiry of Ranitidine Hydrochloride Capsules in the US to the consumer level because of confirmed contamination with N-Nitrosodimethylamine (NDMA) above levels established by the FDA in batches of Sandoz Ranitidine Hydrochloride C TDBBS Voluntarily Recalls Pig Ear Pet Treats No Illnesses Reported; Strictly Precautionary09/24/2019 Food Recall“This recall has been initiated due to possible Salmonella contamination, which poses a health risk. It is important to know that no illnesses have been reported, and the amount of affected product is minimal. Frozen and Refrigerated Cookie Dough Products Recalled Due to Potential Health Risk from Allergens09/24/2019 Food RecallCalifornia New Foods has issued a voluntary recall of frozen and refrigerated cookie dough products due to a lack of labeling that addresses the potential for the products to contain peanut and walnut allergens. Gramco, Inc. Recalls Hog Grower Pellets because of Elevated Vomitoxin Levels09/23/2019 Food RecallGramco, Inc. of Springville, New York is recalling bags of Hog Grower Pellets because it contains levels of vomitoxin (a mycotoxin) that could be harmful to swine growth and potentially fatal to young swine. Frozen and Refrigerated Cookie Dough Products Recalled Due to09/23/2019 Food Recall
California New Foods has issued a voluntary recall of frozen and refrigerated cookie dough products due to a lack of labeling that addresses the potential for the products to contain peanut and walnut allergens. Roland Foods, LLC Initiates a Voluntary Recall of Roland Red Lumpfish Caviar and Roland Black Lumpfish Caviar Due to Possible Health Risk09/21/2019 Food RecallRoland Foods, LLC of New York, New York is initiating a voluntary recall of its red and black lumpfish caviar products, which were manufactured at Ora ehf in Iceland, because they have the potential to be contaminated with Clostridium botulinum. Ridley Block Operations Voluntarily Recalls a Batch of Ultralyx 2416-5 No Other Products are Affected; Distribution was Limited to Georgia and Florida09/20/2019 Food RecallRidley Block Operations is voluntarily recalling one batch of Ultralyx 24-165. The product has been found to be out of specification, with elevated levels of non-protein nitrogen (NPN). The affected product could have adverse health effects on cattle. Updated: Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium / Hydrochlorothiazide Tablets, USP09/20/2019 Food RecallTorrent Pharmaceuticals Limited is expanding its recall for Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity. Abbott Laboratories Recalls Calcilo XD® Infant Formula09/18/2019 Food RecallOut of an abundance of caution, Abbott has voluntarily recalled a single lot of Calcilo XD® powder cans (13.2oz / 375g) with lot number 79696K80 in the United States and Canada due to an inconsistency in aroma and color in a small number of cans from this specific batch. Southeastern Grocers Issues Voluntary Recall Variety pack cookie products sold in Southeastern Grocers stores09/18/2019 Food RecallSoutheastern Grocers (SEG), the parent company of BI-LO, Fresco y Más, Harveys Supermarkets and Winn-Dixie stores, is issuing a voluntary recall for two 18-count cookie products sold in the bakery. The recall is due to the inclusion of an undeclared allergen in the products. SCHWARTZ BROTHERS BAKERY ISSUES ALLERGY ALERT ON UNDECLARED EGG IN LEMON DESSERT BARS09/18/2019 Food RecallSchwartz Brothers Bakery of Seattle, WA is recalling 24 units of Lemon Dessert Bars, sell by date 09/21/19, because it may contain undeclared Egg. People who have an allergy or severe sensitivity to Egg run the risk of serious or life-threatening allergic reaction if they consume these products. Teleflex Medical Recalls the Hudson RCI Sheridan and Sheridan Endotracheal Tubes Due to Risk of the Sheridan Connector Disconnecting from the Breathing Circuit09/17/2019 Medical RecallFDA has classified the voluntary action as a Class I recall for the Teleflex Medical Recalls the Hudson RCI Sheridan and Sheridan Endotracheal Tubes Due to Risk of the Sheridan Connector Disconnecting from the Breathing Circuit Fitoterapia USA Inc. Issues Voluntary Nationwide Recall of MERO MACHO ARTIFICIAL PASSION FRUIT FLAVORED VITAMIN C LIQUID SUPPLEMENT Due to Presence of Active Ingredient Tadalafil09/16/2019 Food RecallFitoterapia USA Inc., is voluntarily recalling 19,000 bottles of MACHO ARTIFICIAL PASSION FRUIT FLAVORED VITAMIN C LIQUID SUPPLEMENT, liquid dietary supplement to the consumer level. FDA analysis has found the product to be tainted with Tadalafil. Tadalafil is an active ingredient in a FDA- approved General Mills Recalls Five Pound Bags of Gold Medal Unbleached All Purpose Flour09/16/2019 Food RecallGeneral Mills announced today a voluntary national recall of five-pound bags of its Gold Medal Unbleached All Purpose Flour with a better if used by date of September 6, 2020. Takeda Issues US Recall of NATPARA® (parathyroid hormone) for Injection Due to the Potential for Rubber Particulate09/16/2019 Food RecallTakeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that the company is issuing a US recall for all doses of NATPARA® (parathyroid hormone) for Injection (25 mcg, 50 mcg, 75 mcg, and 100 mcg). This recall is being conducted after discussions with the FDA and is effec Darmerica LLC Issues Voluntary Nationwide Recall of Quinacrine Dihydrochloride Due to A Labeling Error09/14/2019 Food RecallDarmerica LLC is voluntarily recalling two lots, DR4654A and DL4654A, of Quinacrine Dihydrochloride, bulk API powder packaged in Amber HDPE Bottles to the consumer level. This product is being recalled due to a label mix-up. Product intended for further compounding use by pharmacies labeled as Quin Ibrance (palbociclib), Kisqali (ribociclib), and Verzenio (abemaciclib): Drug Safety Communication - Due to Rare but Severe Lung Inflammation09/13/2019 Medical RecallFDA is warning that Ibrance (palbociclib), Kisqali (ribociclib), and Verzenio (abemaciclib) used to treat some patients with advanced breast cancers may cause rare but severe inflammation of the lungs. Zantac (ranitidine): Safety Information - NDMA Found in Samples of Some Ranitidine Medicines09/13/2019 Medical RecallFDA has learned that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain NDMA. KRS Global Biotechnology, Inc. Issues Voluntary Nationwide Recall of All Human and Animal Sterile Drug Products Due to Lack of Assurance of Sterility09/13/2019 Food RecallKRS Global Biotechnology, Inc. is voluntarily recalling all lots of unexpired human and animal drugs intended to be sterile to the consumer level. The products are being recalled due to lack of assurance of sterility. KRS Global Biotechnology, Inc. Issues Voluntary Nationwide Recall of All Human and Animal Sterile Drug Products Due to Lack of Assurance of Sterility09/13/2019 Food RecallKRS Global Biotechnology, Inc. is voluntarily recalling all lots of unexpired human and animal drugs intended to be sterile to the consumer level. The products are being recalled due to lack of assurance of sterility. Ibrance (palbociclib), Kisqali (ribociclib), and Verzenio (abemaciclib): Drug Safety Communication - Due to Rare but Severe Lung Inflammation09/13/2019 Medical RecallFDA is warning that Ibrance (palbociclib), Kisqali (ribociclib), and Verzenio (abemaciclib) used to treat some patients with advanced breast cancers may cause rare but severe inflammation of the lungs. Urban Remedy Voluntarily Recalls 76 Salads, Wraps That May Contain E.Coli Bacteria No Illnesses Reported, Company Taking Preventive Action09/13/2019 Food RecallUrban Remedy, a California-based producer and retailer of ultra-fresh, organic meals, is voluntarily recalling 76 salads and wraps that contain spinach that may be contaminated with E. coli. Seventy-six salads and wraps are still unaccounted for. No juices or any other products are being recalled. Rong Shing Issues Allergy Alert on Undeclared Eggs and Milk in FuPaiYuan Nougat Candies09/12/2019 Food RecallRONG SHING of Brooklyn, NY is recalling its 450g packages of FuPaiYuan Nougat candy because they may contain undeclared eggs and milk allergens Rong Shing Issues Allergy Alert on Undeclared Eggs and Milk in FuPaiYuan Matcha Candies09/12/2019 Food RecallRONG SHING of Brooklyn, NY is recalling its 450g packages of FuPaiYuan Matcha candy because they may contain undeclared eggs and milk allergens Zantac (ranitidine): Safety Information - NDMA Found in Samples of Some Ranitidine Medicines09/12/2019 Medical RecallFDA has learned that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain NDMA. Stark Group International Issues Allergy Alert on Undeclared Milk Allergens in Ritter Sport KAFFEESPLITTER - 3.5 Ounce /100 Gram09/12/2019 Food RecallStark Group International of Greenvale, NY is recalling all codes of its 100 gram packages of Ritter Sport -KAFFEESPLITTER because they may contain undeclared milk allergens. House Of Spices (India) Issues Recall of "MDH Sambar Masala" Due To Salmonella Contamination09/11/2019 Food RecallHouse of Spices (India) is recalling different lots of “MDH SAMBAR MASALA”, 3.5oz (100g) UPC code 6291103750327.This product is produced by R-PURE AGRO SPECIALITIES and distributed by HOUSE OF SPICES (INDIA). This product was tested by FDA through a certified laboratory to be positive for Salmonella Recall of Yellowfin Tuna Steaks Issued09/11/2019 Food RecallOn September 6, 2019, Alfa International Seafood, Inc. of Medley, FL, voluntarily initiated a recall of refrigerated, wild-caught yellowfin tuna loins because of potentially elevated levels of histamine. Hospira, Inc., Issues A Voluntary Nationwide Recall for one lot of BACTERIOSTATIC WATER for Injection, USP, due to a Potential Lack of Sterility Assurance09/11/2019 Food RecallHospira, Inc., a Pfizer company, is voluntarily recalling BACTERIOSTATIC WATER for Injection, USP, 30 mL, multi-dose vial, lot W20308, to the Hospital/Retail level. Hospira initiated this recall due to lack of confirmation of sterilization for some vials from this lot. Hy-Vee Voluntarily Recalls Several Hy-Vee Mealtime Asian Entrees Due to Undeclared Milk Allergen09/11/2019 Food RecallHy-Vee, Inc., based in West Des Moines, Iowa, is voluntarily recalling seven of its Hy-Vee Mealtime Asian Entrees after discovering the liquid egg used to make the fried rice contains milk, which is not declared on the product label. Tetrahydrocannabinol (THC)-containing Vaping Products: Vaping Illnesses09/09/2019 Medical RecallConsumers are likely aware of the recent reports of respiratory illnesses – including some resulting in deaths – following the use of vaping products.The FDA is working closely with the CDC, as well as state and local public health partners to investigate them as quickly as possible. test article-5/9-FT-Medwatch RSS Feed09/05/2019 Medical Recalltest article-5/9-FT-Medwatch RSS Feed E-Cigarette Products: Safety Communication - Due to the Incidents of Severe Respiratory Disease Associated with Use of an E-Cigarette Product08/30/2019 Medical RecallBoth the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention are working tirelessly to investigate the distressing incidents of severe respiratory disease associated with use of e-cigarette products. Hepatitis C Medicines (Mavyret, Zepatier, and Vosevi): Drug Safety Communication - Due to Rare Occurrence of Serious Liver Injury in Some patients with Advanced Liver Disease08/29/2019 Medical RecallFDA has received reports that the use of Mavyret, Zepatier, or Vosevi to treat chronic Hepatitis C in patients with moderate to severe liver impairment has resulted in rare cases of worsening liver function or liver failure. Xeljanz, Xeljanz XR (tofacitinib): Drug Safety Communication - Due to an Increased Risk of Blood Clots and Death with Higher Dose07/26/2019 Medical RecallDrug Safety Communication - Due to an Increased Risk of Blood Clots and Death with Higher Dose Fecal Microbiota for Transplantation: Safety Communication- Risk of Serious Adverse Reactions Due to Transmission of Multi-Drug Resistant Organisms06/19/2019 Medical RecallFDA MedWatch Alert regarding Fecal Microbiota for Transplantation: Safety Communication- Risk of Serious Adverse Reactions Due to Transmission of Multi-Drug Resistant Organisms E-cigarette: Safety Communication - Related to Seizures Reported Following E-cigarette Use, Particularly in Youth and Young Adults05/16/2019 Medical RecallSafety Communication - Related to Seizures Reported Following E-cigarette Use, Particularly in Youth and Young Adults Certain Prescription Insomnia Medicines: New Boxed Warning - Due to Risk of Serious Injuries Caused by Sleepwalking, Sleep Driving and Engaging in Other Activities While Not Fully Awake04/30/2019 Medical RecallMedWatch Alert on certain prescription insomnia medicines. Teva Pharmaceuticals USA, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium 25 mg and 100 mg Tablets USP, Sold Exclusively to Golden State Medical Supply04/26/2019 Food RecallTeva Pharmaceuticals USA, Inc. has initiated a voluntary recall in the United States, to the patient level, of 35 lots of bulk Losartan Potassium USP Tablets (6 lots of 25 mg strength and 29 lots of 100 mg strength). Legacy Pharmaceutical Packaging, LLC Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 50mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity Found in the Active Pharmaceutical Ingredien04/25/2019 Food RecallLegacy Pharmaceutical Packaging, LLC is expanding its consumer-level recall of 3 repackaged lots Losartan Tablets USP 50mg to include one additional lot. Jurox Incorporated is Voluntarily Recalling Two Lots of Alfaxan Unpreserved, an Intravenous Injectable Anaesthetic04/24/2019 Food RecallThis recall has been initiated due to an out of specification result for clarity observed in the stability program. The presence of the aluminum phosphate precipitate presents a potential risk that intravascular (I.V.) injection of product containing this precipitate could result in blood vessel in Alvogen Inc. Issues Voluntary Nationwide Recall of Fentanyl Transdermal System Due to Product Mislabeling04/21/2019 Food RecallAlvogen, Inc. is voluntarily recalling two lots of Fentanyl Transdermal System 12 mcg/h transdermal patches to the consumer level. Updated: Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium/Hydrochlorothiazide Tablets, USP04/18/2019 Food RecallTorrent Pharmaceuticals Limited is expanding its recall for Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. The Recall is expanded to include an additional 36 lots of Losartan potassium Tablets USP and 68 lots of Losartan Potassium/Hydrochlorothiazide Tablets, USP Weis Markets Issues Recall for Undeclared Egg Allergen In WQ Banana Puddin Ice Cream04/17/2019 Food RecallWeis Markets today said it has issued a recall for its Weis Quality Banana Puddin Ice Cream (48oz) since the product’s ingredient label fails to list an egg allergen due to a supplier error. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction if they consume these products. There have been no reports of illness from customer’s consuming this product to date. Mondelēz Global LLC Conducts Voluntary Recall of Certain Chewy Chips Ahoy 13oz Due to Unexpected Solidified Ingredient in Product in the US04/17/2019 Food RecallMondelēz Global LLC announced today a limited voluntary recall in the United States of certain Chewy Chips Ahoy 13oz cookies. This voluntary recall is being conducted because of the potential for certain product to contain an unexpected solidified ingredient. Some reports of potential adverse health effects have been received. Jensen Tuna of Louisiana is Voluntarily Recalling Frozen Ground Tuna Imported from JK Fish, Because it may Potentially be Contaminated with Salmonella04/16/2019 Food RecallJensen Tuna of Louisiana is Voluntarily Recalling Frozen Ground Tuna Imported from JK Fish, Because it may Potentially be Contaminated with Salmonella. The frozen product, individually packaged in clear plastic one-pound bags, is sold in white wax 20 lb. boxes. The product is only sold as a wholesale case with twenty bags in each case. The lot numbers are z266, z271 and z272. Hercules Candy LLC Issues Allergy Alert on Undeclared Peanuts in Cashew Brittle Bits04/16/2019 Food RecallHercules Candy LLC . of East Syracuse, NY, is recalling its 4 ounce packages of Cashew Brittle Bits because they may contain undeclared peanuts. People who have allergies to peanuts run the risk of serious or life-threatening allergic reaction if they consume this product. The recalled Cashew Brittle Bits were distributed from the brick and mortar retail in East Syracuse and nationally through the website www.herculescandy.com. Unilever Issues Allergy Alert on Undeclared Tree Nut in Limited Quantities of Ben & Jerry’s Coconut Seven Layer Bar Bulk and Chunky Monkey Pint04/16/2019 Food RecallUnilever is voluntarily recalling a limited quantity of Ben & Jerry’s Coconut Seven Layer Bar bulk and Ben & Jerry’s Chunky Monkey pints, which may inadvertently contain tree nuts including almonds, Brazil nuts, and hazelnuts that are not declared in the ingredient list or allergy information list. Both affected products include a “Contains Walnuts” and a “May contain other tree nuts” label on the back of the pack. Persons who have an allergy or severe sensitivity to these undeclared tree nuts run the risk of a serious or life-threatening allergic reaction if they consume the recalled products. Caito Foods, LLC Voluntarily Recalls Fresh Cut Melon Product Because of Possible Health Risk04/13/2019 Food RecallCaito Foods is voluntarily recalling fresh cut watermelon, fresh cut honeydew melon, fresh cut cantaloupe and fresh cut mixed fruit containing one of these melons, produced at the Caito Foods facility in Indianapolis because these products have the potential to be contaminated with Salmonella Carrau, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. SD Import Issues Voluntary Nationwide Recall of Aphrodisiac Capsules Due to Presence of Undeclared Sildenafil04/11/2019 Food RecallSD Import, LLC is voluntarily recalling all lots of Aphrodisiac, Capsules to the consumer level. The products have been found to be tainted with sildenafil. FDA analysis has found the product to be tainted with sildenafil. Sildenafil is an active pharmaceutical ingredient in FDA approved product used in the treatment of erectile dysfunction. The presence of sildenafil in Aphrodisiac capsules renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. Great American Marketing Company Recalls Ready To Eat Products Because of Possible Health Risk04/10/2019 Food RecallGreat American Marketing Company of Houston, Texas is recalling Ready to Eat Sandwiches, Wraps and Salads because they have the potential to be contaminated with LISTERIA MONOCYTOGENES , an organism which can cause serious and sometimes fatal infections in young children, frail and elderly people and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria Infection can cause miscarriages and still births among pregnant women. Brian Richardson DBA “In Tha Pink” Issues Voluntary Nationwide Recall of Kopi Jantan Tradisional Natural Herbs Coffee Due to Presence of Undeclared Sildenafil and Tadalafil04/08/2019 Food RecallBrian Richardson DBA “In Tha Pink”, is voluntarily recalling lots with the expiration of October 13, 2020 (13/10/2020) of ground Kopi Jantan Tradisional Natural Herbs Coffee to the consumer level. FDA analysis has found the product to be tainted with Sildenafil and Tadalafil Thorgensen Family Farm Recalls Raw Frozen Ground Pet Food (Rabbit; Duck; Llama; Pork) Because of Possible Listeria Monocytogenes Health Risk04/07/2019 Food RecallThogersen Family Farm of Stanwood, WA is voluntarily recalling raw frozen ground pet food because it has the potential to be contaminated with Listeria monocytogenes. The following varieties, packaged in two pound packs, are included in this recall: course ground rabbit, course ground mallard duck, ground llama, and ground pork frozen raw pet food Conagra Brands Announces Recall of a Limited Amount of Hunt’s Tomato Paste Cans Due to Potential Presence of Mold04/04/2019 Food RecallConagra Brands, Inc. (NYSE: CAG) is voluntarily recalling a limited amount of Hunt’s Tomato Paste No Salt Added six ounce cans. After the canning process, the final product could have been damaged, creating the potential for mold. Conagra Brands became aware of the issue after receiving calls from consumers. E-cigarette: Safety Communication - Related to Seizures Reported Following E-cigarette Use, Particularly in Youth and Young Adults04/03/2019 Medical RecallThe FDA has become aware that some people who use e-cigarettes have experienced seizures, with most reports involving youth or young adult users. Wakefern Food Corp. Voluntarily Recalls Wholesome Pantry Organic Nut Butters Because of Possible Health Risk04/02/2019 Food RecallWakefern Food Corp. has initiated a voluntary recall of a variety of Wholesome Pantry Organic nut butters because they may be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. No illnesses related to the recall have been reported. NadaMoo! Voluntarily Recalls Select Pints of Strawberry Cheesecake Due to Undeclared Almond04/01/2019 Food RecallLittle Red Rooster Ice Cream Company, d/b/a NadaMoo! (“NadaMoo!”) announced a limited voluntary recall of approximately 26,000 pints of its Strawberry Cheesecake Non-Dairy Frozen Dessert because they contain an undeclared almond ingredient. People who have an allergy or severe sensitivity to almonds run the risk of a serious or life-threatening allergic reaction if they consume the recalled products. Nestle Purina PetCare Company Voluntarily Recalls a Limited Amount of Muse Wet Cat Food Natural Chicken Recipe in Gravy in Three-ounce Cans due to the Potential Presence of Rubber Pieces03/30/2019 Food RecallOut of an abundance of caution, Nestle Purina PetCare Company is voluntarily recalling a limited amount of Muse wet cat food Natural Chicken Recipe in Gravy in three-ounce cans. The product could contain rubber pieces that are translucent yellow with a blue backing, which may present a potential choking hazard. Thomas Hammer Coffee Roasters Inc. Issues Allergy Alert on Undeclared Egg in Blueberry Bread03/29/2019 Food RecallThomas Hammer Coffee Roasters Inc. of Spokane, WA is recalling 15 loaves of Blueberry Bread because it may contain undeclared EGG. People who have an allergy or severe sensitivity to egg run the risk of serious or life-threatening allergic reaction if they consume this product. Theo Chocolate Issues Allergy Alert on Undeclared Milk in 3oz Sea Salt 70% Dark Chocolate Bars03/28/2019 Food RecallTheo Chocolate of Seattle, WA is voluntarily recalling 3oz Sea Salt 70% Dark Chocolate bars (UPC 8 74492 00325 8) because they may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume this product. USA LESS Issues Voluntary Nationwide Recall of LEOPARD Miracle Honey Due to Presence of Undeclared Sildenafil03/25/2019 Food RecallUSA LESS, is voluntarily recalling all lots of LEOPARD Miracle Honey, to the consumer level. FDA analysis has found LEOPARD Miracle Honey to be tainted with sildenafil. Henry Avocado Recalls Whole Avocados Because Of Possible Health Risk03/24/2019 Food RecallHenry Avocado Corporation is voluntarily recalling California-grown whole avocados sold in bulk at retail stores because they have the potential to be contaminated with Listeria monocytogenes. Henry Avocado is issuing this voluntary recall out of an abundance of caution due to positive test results on environmental samples taken during a routine government inspection at its California packing facility. There are no reported illnesses associated with this recall. Ata Int. Inc. Issues Voluntary Nationwide Recall of BLUEFUSION Capsules, due to presence of Undeclared Sildenafil, Tadalafil, Desmethyl carbodenafil, Dithiodesmethyl carbodenafil, Scutellarin and Daidzein03/21/2019 Food RecallAta Int. Inc. is voluntarily recalling all lots within expiry of BLUEFUSION Capsules to the consumer level. FDA analysis has found the product to be tainted with sildenafil, tadalafil, desmethyl carbodenafil, dithiodesmethyl carbodenafil, scutellarin and daidzein. Sildenafil and tadalafil are FDA approved drugs for the treatment of male erectile dysfunction and are in a class of drugs called phosphodiesterase (PDE-5) inhibitors. Desmethyl carbodenafil and dithiodesmethyl carbodenafil are analogues of PDE-5 inhibitors and are likely to have the same pharmacological activity as PDE-5 inhibitors and thus carry the same clinical risks. Scutellarin and daidzein are derived from plants or herbs. Hill’s Pet Nutrition Expands Voluntary Recall of Select Canned Dog Food for Elevated Vitamin D03/21/2019 Food RecallHill’s Pet Nutrition today announced it is expanding its recall of select canned dog food products due to elevated levels of vitamin D. Better Made Snack Foods Issues Allergy Alert on Undeclared Milk In 10 Ounce $3.99 Original Potato Chips03/21/2019 Food RecallThe recall was initiated after it was discovered that a package of 10-ounce Original Potato Chips dated 10 AUG 2019 did not contain Original Potato Chips but instead contained Cheddar and Sour Cream Potato Chips which contain milk. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company's production and packaging processes which may have affected 660 bags of 10-ounce Original Potato Chips. Century Snacks LLC Recalls Snak Club Honey Bliss Nut Mix Due to Undeclared Allergen03/21/2019 Food RecallCentury Snacks, LLC of Commerce, CA is recalling all packages of 3-oz. and 5.75-oz. SNAK CLUB HONEY BLISS NUT MIX due to undeclared MILK. People who have an allergy or severe sensitivity to MILK run the risk of serious or life-threatening allergic reaction if they consume these products. Kingston Pharma, LLC RECALLS " DG™/health NATURALS baby Cough Syrup + Mucus” Because of Possible Health Risk03/20/2019 Food RecallKingston Pharma, LLC of Massena, NY is recalling Lot KL180157 of its 2-fluid ounce (59 mL) bottles of DG™/health NATURALS baby Cough Syrup + Mucus” because it has the potential to be contaminated with Bacillus cereus/ Bacillus circulans. Bacillus cereus in food products has the potential to produce two forms of gastrointestinal illness, one being a syndrome primarily of vomiting, and the other of diarrhea. Most often, illnesses are mild and self-limiting, although more serious and even lethal cases have occurred. Individuals at risk for more severe forms of illness include infants, young children, and others with weakened immune systems. No illnesses have been reported to date in connection with this problem with the use of DG™/health NATURALS baby Cough Syrup + Mucus. Mylan Institutional LLC Initiates Voluntary Nationwide Recall of Levoleucovorin Injection Due to the Presence of Particulate Matter03/18/2019 Food RecallMylan Institutional LLC is conducting a voluntary nationwide recall of two lots (see table below) of Levoleucovorin Injection, 250 mg/25 mL to the consumer/user level. The lots were manufactured by Alidac Pharmaceuticals Limited and distributed by Mylan Institutional LLC. Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 50mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical Ingredient03/16/2019 Food RecallLegacy Pharmaceutical Packaging, LLC is recalling 3 repackaged lots of Losartan Tablets USP 50mg to the consumer level. This recall was prompted due to Torrent Pharmaceuticals LTD issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer). Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25mg, 50mg, And 100mg Due to The Detection of Trace Amounts Of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Impurity Found in The Active Pharmace03/15/2019 Food RecallEarth City, MO, Legacy Pharmaceutical Packaging, LLC is recalling 40 repackaged lots of Losartan Tablets USP 25mg, 50mg, and 100mg to the consumer level. This recall was prompted due to Camber Pharmaceuticals, Inc. issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer). Hospira, Inc. Issues a Voluntary Nationwide Recall of 8.4% Sodium Bicarbonate Injection, USP Due to the Presence of Particulate Matter03/15/2019 Food RecallHospira, Inc., a Pfizer company, is voluntarily recalling lot numbers 79-238-EV, 79-240-EV and 80-088-EV, NDC# 0409-6625-02, of 8.4% Sodium Bicarbonate Injection USP, 50 mEq/50 mL (1 mEq/mL), to the Hospital/Institution level. The recall was initiated due to the presence of particulate matter, confirmed as glass. Surtidoras Bakery Inc. Issues Allergy Alert on Undeclared Milk in Marble Muffin, Banana Muffin, and Blueberry Muffin03/15/2019 Food RecallSurtidoras Bakery Inc. of Auburn, Washington is recalling Marble Muffin, Banana Muffin, and Blueberry Muffin because it may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products. Stokes Healthcare Inc. Issues Voluntary Nationwide Recall of Pilocarpine 0.1% Ophthalmic Solution Due to a High Level of Preservative03/13/2019 Food RecallStokes Healthcare Inc. is voluntarily recalling 1 lot of 81 units of Pilocarpine 0.1% Ophthalmic Solution, to the consumer and veterinarian office levels. The ophthalmic solution has been found to contain a higher level of the preservative benzalkonium chloride than is typical. Hometown Food Company Recalls Two Production LOT Codes of Pillsbury® Unbleached All-Purpose 5lb Flour Due to Possible Health Risk03/13/2019 Food RecallPlease be advised the Hometown Food Company initiated a limited, voluntary retail-level recall on two specific lot codes of its Pillsbury® Unbleached All-Purpose 5 lb Flour (UPC 51500-22241) because it may be contaminated with Salmonella. Only Best If Used By Dates APR 19 2020 and APR 20 2020 are impacted. Claire’s Stores, Inc., Announces Voluntary Recall of Three Make-Up Products03/12/2019 Food RecallOut of an abundance of caution, today Claire’s Stores, Inc., announced a voluntary recall of three cosmetic products: Claire’s Eye Shadows, Claire’s Compact Powder and Claire’s Contour Palette. We initiated this voluntary recall after testing by the U.S. Food and Drug Administration indicated the possible presence of asbestos fibers in product samples from one lot of each product. Inhalation of asbestos over time has been linked to serious adverse health consequences. Fullei Fresh Recalls Organic Bean Sprouts Because of Possible Health Risk03/08/2019 Food RecallFullei Fresh of Miami, Florida is voluntarily recalling Organic Bean Sprouts because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Norbrook Laboratories Limited Recalls Veterinary Products for Health Risk03/07/2019 Food RecallNorbrook Laboratories Limited of Newry, Northern Ireland is recalling two lots of Enroflox® 100 Injection (enrofloxacin), two lots of Noromectin® Injection (ivermectin) and two lots of Ivermax® 1% Injection (ivermectin) to the veterinarian/consumer level as a precautionary measure as product sterility cannot be assured. There is a concern that if the sterility of these products has been compromised, use of these products could result in introduction of infectious agents to the animal. This may result in the need for medical intervention(s) including, but not limited to the need for supportive care, antibiotics, and/or antifungal drugs. American Health Packaging Issues Voluntary Nationwide Recall of Valsartan Tablets Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity03/07/2019 Food RecallAmerican Health Packaging is voluntarily recalling one lot of Valsartan Tablets, USP, 160 mg to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the finished drug product is N-Nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification. This recall is being initiated in response to the recall by the manufacturer (Aurobindo Pharma USA, Inc.), which included the affected lot that was repackaged by American Health Packaging. McDaniel Life-Line LLC Issues Voluntary Worldwide Recall of Life-Line Water03/06/2019 Food RecallMcDaniel Life-Line LLC is voluntarily recalling all lots of Life-Line Water to the consumer level. This product is being recalled because FDA analysis found the product to be contaminated with Pseudomonas aeruginosa. Apotex Corp. Issues Voluntary Nationwide Recall of Drospirenone and Ethinyl Estradiol Tablets, USP, 28x3 Blister Pack/Carton Due to Possibility of Missing/Incorrect Tablet Arrangement03/04/2019 Food RecallWeston, Florida, Apotex Corp. is voluntarily recalling four lots of Drospirenone and Ethinyl Estradiol Tablets, USP to the patient /user level. The four recalled lots of Drospirenone and Ethinyl Estradiol Tablets, USP may possibly contain defective blisters with incorrect tablet arrangements and/or an empty blister pocket. The affected product is manufactured by Oman Pharmaceutical Products Co. LLC. Oman under the subcontract from Helm AG, Nordkanalstrasse 28, Hamburg, 20097, Germany. Sunstone Organics Issues Voluntary Nationwide Recall of Select Kratom Products Due to Potential Contamination by Salmonella03/01/2019 Food RecallSpringfield, OR, Sunstone Organics is voluntarily recalling two lots of Sunstone Organics Kratom. These two lots include Sunstone Organics White Vein Kratom Lot 119 and Sunstone Organics Maeng Da Kratom Lot 124A in both capsules and powder form and in all sizes. The products have been found to potentially be contaminated with salmonella. Updated: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium /Hydrochlorothiazide Tablets, USP03/01/2019 Food RecallTorrent Pharmaceuticals Limited is voluntarily recalling 60 lots of Losartan potassium tablets USP and 54 lots of Losartan potassium/ hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. Asia Foods Distributor Inc. Issues Allergy Alert on Undeclared Milk Allergens in “Nova Salted Biscuit”03/01/2019 Food RecallAsia foods Distributor Inc of 56-29 56 Drive, Maspeth, NY 11378 is recalling its 14.08 ounce packages of “Nova Salted Biscuit” food treats because they may contain undeclared milk allergens. Consumers who are allergic to milk allergens may run the risk of serious or lifethreatening allergic reactions if they consume this product. AurobindoPharma USA, Inc. Initiates a Voluntary Nationwide Consumer Level Recall Expansion of 38 Lots of Amlodipine Valsartan Tablets USP and Valsartan Tablets, USP due to the detection of NDEA (N-Nitrosodiethylamine) Impurity.03/01/2019 Food RecallAurobindoPharma USA, Inc. is conducting a voluntary recall expansion of 38 lots of Valsartan and Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. This recall is an expansion of the recall initiated 12/31/18 The impurity detected in the finished drug product is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification. The expansion relates to lots distributed under the labels for AurobindoPharma USA, Inc. and Acetris Health, LLC. To date, AurobindoPharma USA, Inc. has not received any reports of adverse events related to this recall. Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25 mg, 50 mg and 100 mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical03/01/2019 Food RecallCamber Pharmaceuticals, Inc. is recalling 87 lots of Losartan Tablets USP 25 mg, 50 mg, and 100 mg to consumer level. This recall was prompted due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit – I (API manufacturer). Joy Gourmet Foods LLC Issues Allergy Alert on Undeclared Sulfites02/27/2019 Food RecallJoy Gourmet Foods Inc. of Maspeth, NY is recalling its Joy Brand Chutneys and Pastes products because they contain undeclared sulfites.. People who have allergies to sulfites run the risk of serious or life-threatening allergic reaction if they consume this product. The recalled Joy Brand Chutneys and Pastes were distributed in NY, NJ,and CT in retail stores.The products comes in 8 oz,14 oz,16 oz, and 26 oz, 32 oz. clear glass jar packages and marked on the labels as follows: UTZ Quality Foods Issues Allergy Alert on Undeclared Milk in Bachman 10 Ounce Twist02/26/2019 Food RecallUtz Quality Foods, LLC., is voluntarily recalling a specific expiration date code of Bachman 10 oz Twist Pretzel packages due to undeclared milk. This recall was initiated after reviewing production records which identified a small number of packages were mislabeled. ICU Medical Issues a Voluntary Nationwide Recall of Certain Lots of ChemoLock™ and ChemoClave® Vial Spikes Due to the Potential for Burr Particulate02/26/2019 Food RecallICU Medical, Inc. today announced a voluntary recall of certain lots of ChemoLock™ and ChemoClave® Vial Spikes due to the potential for burr particulate originating from the protective cap used in the assembly of the device Southern Specialties Voluntarily Recalls Bagged Green Beans and Butternut Squash Distributed in Southeast because of Possible Health Risk02/25/2019 Food RecallSouthern Specialties Inc. of Pompano Beach, Florida is voluntarily recalling select bags of Marketside brand green beans and butternut squash because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Golean Detox USA Issues Voluntary Nationwide Recall of Golean DETOX Capsules Due to Presence of Undeclared Sibutramine and Phenolphthalein02/25/2019 Food RecallGolean Detox USA, Charlotte, NC is voluntarily recalling all lots within expiry of Golean DETOX capsules to the consumer level. FDA analysis has found Golean DETOX capsules to be tainted with undeclared sibutramine and phenolphthalein. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market due to safety concerns. Phenolphthalein was once an ingredient used in over-the-counter laxatives, but because of concerns of carcinogenicity is not currently approved for marketing in the United States. The presence of sibutramine and phenolphthalein in Golean DETOX renders it an unapproved drug for which safety and efficacy has not been established and, therefore, subject to recall. B&G Foods Voluntarily Recalls a Limited Number of Jars of Victoria® Marinara Sauce Due to Possible Undeclared Cashew02/25/2019 Food RecallB&G Foods announced today it is voluntarily recalling 1,280 cases of a single date code of 40 oz. Victoria Marinara Sauce, with a “best by” date of 03/06/2022, after learning that the product may contain cashew allergens that are not declared on the product’s ingredient statement. People who have an allergy or severe sensitivity to cashew run the risk of serious or life-threatening allergic reaction if they consume this product. There is no health risk associated with this product for individuals without an allergy to tree nuts. Macleods Pharmaceuticals Limited Issues Voluntary Nationwide Consumer Level Recall of One Lot (BLM 715A) of Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg Due to detection of NDEA (N-Nitrosodiethylamine) Impurity02/25/2019 Food RecallMacleods Pharmaceuticals Limited is voluntarily recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg to the consumer level due to the detection of trace amounts of an unexpected impurity (NDEA) found in finished product manufactured with active pharmaceutical ingredient made by Hetero Labs Limited. Xeljanz, Xeljanz XR (tofacitinib): Safety Communication - Safety Trial Finds Increased Risk of Blood Clots in the Lungs and Death with Higher Dose in Rheumatoid Arthritis Patients02/25/2019 Medical RecallFDA is alerting the public that a safety clinical trial found an increased risk of blood clots in the lungs and death when a 10 mg twice daily dose of tofacitinib (Xeljanz, Xeljanz XR) was used in patients with rheumatoid arthritis (RA). FDA has not approved this 10 mg twice daily dose for RA; this dose is only approved in the dosing regimen for patients with ulcerative colitis Meijer Recalls Mint Meijer Brand Ultimate Chocolate Mint Chip Cookies Due to an Undeclared Soy Allergen02/22/2019 Food RecallMeijer is announcing a voluntary recall of its Meijer brand Ultimate Chocolate Mint Chip Cookies because soy it is not properly declared on the label. Jacques Torres Manufacturing LLC Issues Allergy Alert on Undeclared Milk Allergens in “Jacques” Big Daddy Dark Chocolate Bar02/21/2019 Food RecallJacques Torres Manufacturing LLC of Brooklyn, New York is recalling its 2.2 lbs. (1kg), “Jacques” Big Daddy Dark Chocolate Bar, because it contains undeclared milk allergens. Consumers who are allergic to milk allergens may run the risk of serious or life-threatening allergic reaction if they consume this product. Gilda Industries, Inc. Issues Allergy Alert on Undeclared Milk in Butter Pound Cake02/20/2019 Food RecallGilda Industries, Inc voluntarily recalls select code dates and manufacturing lot numbers of Panque – Butter pound cake because they may contain undeclared milk . People who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume the product contained inside the recalled panque –butter pound cake Concord Fresh Success Recall Mild Salsa Seasoning Mix Due To Undeclared Milk Allergen02/19/2019 Food RecallConcord Foods, LLC of Brockton, Massachusetts is recalling Concord Fresh Success Mild Salsa Seasoning Mix because it may contain undeclared milk allergen. People who have an allergy or severe sensitivity to milk allergen run the risk of serious or lifethreatening allergic reaction if they consume this product. Chukar Cherries Expands Recall Of Amaretto Rainier Ultra Dark Chocolate Cherries Pouches Due To Undeclared Milk02/18/2019 Food RecallFebruary 18, 2019, Chukar Cherries of Prosser, WA is recalling 7.5oz Amaretto Rainier Ultra Dark Chocolate Cherries because they may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume this product. Smoked Alaska Seafoods, Inc. Recalls 6.5 oz Jars & Cans of Smoked Silver Salmon Because of Possible Health Risk02/16/2019 Food RecallSmoked Alaska Seafoods, Inc. of Wasilla, AK is recalling all jars and cans of Smoked Silver Salmon in 6.5 oz. containers with the production code of AL81111133 on the bottom of the jar/can because it has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled. Nature’s Path Foods Recalls A Specific Production Run Of Envirokidz Choco Chimps, Gorilla Munch And Jungle Munch Cereals Due To Undeclared Gluten02/16/2019 Food RecallToday, Nature’s Path Foods announced a voluntary recall of a specific production run of EnviroKidz Choco Chimps, Gorilla Munch and Jungle Munch cereals for they may contain undeclared gluten (wheat and barley). People who have a wheat allergy, celiac disease or sensitivity to gluten and wheat should not consume the cereals with the BEST BEFORE DATE listed below due to potential adverse health effects. Nature’s Path is also removing any affected cereals from customer store shelves and warehouses. Kingston Pharma, LLC Issues Voluntary Recall of All Lots of “DG™ Baby Gripe Water Due to Undissolved Ingredient, Citrus Flavonoid02/15/2019 Food RecallKingston Pharma, LLC is voluntarily recalling all lots of “DG™ Baby Gripe Water herbal supplement with organic ginger and fennel extracts” to the consumer level due to the presence of an undissolved ingredient, citrus flavonoid. Sid Wainer and Son Initiates Class 2 Recall for Jansal Valley Dukkah Due to Potential Glass Pieces02/15/2019 Food RecallSid Wainer and Son of New Bedford, MA is voluntarily recalling Jansal Valley brand Dukkah in 2.5oz containers because of the potential of it containing glass pieces Ottogi America, Inc. Expands Recall on Undeclared Egg in Products02/13/2019 Food RecallOttogi America, Inc. announced today it is expanding its recall to include the two items below due to a possibility of containing egg ingredient undeclared on the packages. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction of they consume these products. World Waters Issues Voluntary Recall of Select WTRMLN WTR Original 12 Packs Due To The Possible Presence of Soft Plastic Pieces. Company Urges Consumers to Check Packages Prior to Consumption02/11/2019 Food RecallWorld Waters, LLC is initiating a voluntary recall of certain lots of Cold Pressed Juice Watermelon WTRMLN WTR Original 12 packs due to the potential presence of soft plastic that may be loosely floating in some of the finished products Birdseed Food Co. Issues Allergy Alert on Undeclared Cashews in Craft Granola Goldenola Turmeric & Ginger02/09/2019 Food RecallBIRDSEED FOOD CO. of Bend, OR is recalling Craft Granola Goldenola Turmeric & Ginger that was sold between the dates of 10/03/18 - 02/07/19, because it contains undeclared cashews. People who have an allergy or severe sensitivity to cashews run the risk of serious or life-threatening allergic reaction if they consume this product. McDaniel Life-Line LLC Issues Voluntary Worldwide Recall of Indian Herb02/08/2019 Food RecallFelt, OK, McDaniel Life-Line LLC is voluntarily recalling all lots of Indian Herb to the consumer level. This product is being recalled because it is marketed without an approved NDA/ANDA. The therapeutic claims made in the labeling for this product establish that it is a drug because it is an article (other than food) intended to affect the structure or any function of the body. Additionally, the product contains ingredients that the Agency has determined to be caustic in nature that can cause serious injury. Frito-Lay Issues Voluntary Allergy Alert on Undeclared Milk In Small Number of Stacy’s Simply Naked Pita Chips02/05/2019 Food RecallFrito-Lay announced a limited voluntary recall of a very small number of 7 1/3 oz. bags of Stacy’s Simply Naked Pita Chips because they may contain undeclared milk ingredients. People who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume the product contained inside the recalled pita chips bags. Allergy Alert Issued by Santa Rosa Whole Foods Market for Undeclared Walnut, Milk and Eggs in “Hipster Chipster” Cookies02/05/2019 Food RecallThe Santa Rosa Whole Foods Market store is voluntarily recalling eight packages of its “Hipster Chipster” cookies because they contain undeclared tree nut (walnut), milk, and egg allergens that were not listed on the product label. Dr. Reddy's Laboratories Continues its Voluntary Nationwide Recall of Levetiracetam in 0.54% Sodium Chloride Injection 1500mg/100mL Due to Mislabeling02/04/2019 Food RecallDr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) announced that it’s wholly owned subsidiary, Dr Reddy’s Laboratories, Inc is continuing its voluntary nationwide recall of lot ABD807 of Levetiracetram in 0.54% Sodium Chloride Injection, 1,500 mg/100 mL (15 mg/mL) single-dose infusion bags to the hospital level in U.S.A. Stryker Launches Voluntary Field Action for Specific Units of the LIFEPAK® 15 Monitor/Defibrillator02/01/2019 Food RecallThe company is notifying certain LIFEPAK 15 customers of an issue that may cause the device to lock up after a defibrillation shock is delivered. The lock-up condition is defined as a blank monitor display with LED lights on, indicating power to the device, but no response in the keypad and device functions. A device in this condition has the potential to delay delivery of therapy, and this delay in therapy has the potential to result in serious injury or death. Hill’s Pet Nutrition Voluntarily Recalls Select Canned Dog Food for Excessive Vitamin D01/31/2019 Food RecallHill’s Pet Nutrition is voluntarily recalling select canned dog food products due to potentially elevated levels of vitamin D. While vitamin D is an essential nutrient for dogs, ingestion of elevated levels can lead to potential health issues depending on the level of vitamin D and the length of exposure, and dogs may exhibit symptoms such as vomiting, loss of appetite, increased thirst, increased urination, excessive drooling, and weight loss. Vitamin D, when consumed at very high levels, can lead to serious health issues in dogs including renal dysfunction. Pet parents with dogs who have consumed any of the products listed and are exhibiting any of these signs should contact their veterinarian. In most cases, complete recovery is expected after discontinuation of feeding. Tris Pharma, Inc Expands Its Voluntary Nationwide Retail Recall of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, Due to Higher Concentration of Ibuprofen01/30/2019 Food RecallMonmouth Junction, NJ, Tris Pharma, Inc. is expanding the scope of its November 2018 recall by adding three (3) additional lots of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, to the retail (pharmacy) level. Some units from these batches have been found to have higher levels of Ibuprofen concentration. Nature’s Rx Issues Voluntary Nationwide Recall of Silver Bullet 10x to Undeclared PDF-5 Inhibitors in the Product01/30/2019 Food RecallNature’s Rx is voluntarily recalling quantity lots of Silver Bullet 10x, description of dosage form to the hospital, retail or consumer level. This recall has been initiated because the product was found to contain undeclared sildenafil and tadalafil, the active ingredient in Viagra and Cialis respectively, which are PDE-5 inhibitors. The undeclared PDE-5 inhibitors in the product may pose serious health risks because consumers with underlying medical issues may take the products without knowing that they can cause serious harm or interact in dangerous ways with other drugs they may be taking Purina Animal Nutrition Voluntarily Recalling Purina® Honor® Show Chow® Showlamb Grower Due to Elevated Copper Level01/29/2019 Food Recall)– Purina Animal Nutrition is voluntarily recalling two lots of Purina® Honor® Show Chow® Showlamb Grower due to elevated copper levels. The feed is packaged in purple branded Purina Honor Show Chow bags. Oskri Organics Corporation Recalls All Nut Butters because of Possible Health Risk01/29/2019 Food RecallOskri Organics Corporation of Lake Mills, WI is recalling ALL Oskri Corporation manufactured nut butters. This recall has been initiated due to positive test results for Listeria monocytogenes found in multiple Oskri Corporation manufactured nut butters. SL: Recall of Thrive Market Nut Butters Due to Potential Health Risk01/25/2019 Food RecallThrive Market, Inc, is recalling all unexpired lots of the Thrive Market-branded nut butters listed below (“Product(s)”) due to the potential for contamination with Listeria monocytogenes. On January 21, 2019, one of our suppliers notified us that it was issuing a recall of all nut butters it has manufactured since January 2018 because of a positive test for Listeria monocytogenes in recent lots. Because the safety of our members is our absolute priority, we are expanding on our supplier’s recall and are voluntarily recalling all unexpired lots of all Thrive Market-branded nut butters manufactured by this supplier. Mrs. Grissom’s Salads Issues a Voluntary Recall01/25/2019 Food RecallFor immediate release- January 18,2019 – Nashville, TN – Mrs. Grissom’s Salads is voluntarily recalling a single days production of Mrs. Grissom’s SELECT Old Fashioned Pimento Cheese because of a labeling issue. Product produced on December 13, 2018 may have been packaged incorrectly, with the correct Pimento Cheese label on top lid, but a Chicken salad label on the container. The Pimento Cheese may contain allergens not listed on the products ingredient label, Specifically Milk. Jac. Vandenberg, Inc. Recalls Fresh Peaches, Fresh Nectarines and Fresh Plums Because They May Be Contaminted with Listeria Monocytogenes01/25/2019 Food RecallJac. Vandenberg, Inc. of Yonkers, New York is recalling 1,727 cartons of Fresh Peaches, 1,207 cartons of Fresh Nectarines and 365 cartons of Fresh Plums because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Satur Farms’ Recall of Baby Spinach Affects Prepared Food Items from Whole Foods Market Stores in Eight States01/25/2019 Food RecallIn response to a recall by Satur Farms, Whole Foods Market is voluntarily recalling various prepared foods items in eight states containing baby spinach because of a potential contamination of Salmonella. Product Recall Because of Possible Health Risk01/24/2019 Food RecallSatur Farms, 3705 Alvah's Lane, Cutchogue, NY 11935 is voluntarily recalling Baby Spinach and Mesclun with the specific lot numbers listed below because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. General Mills Recalls Five Pound Bags of Gold Medal Unbleached Flour01/24/2019 Food RecallGeneral Mills announced today a voluntary national recall of five-pound bags of its Gold Medal Unbleached Flour with a better if used by date of April 20, 2020. The recall is being issued for the potential presence of Salmonella which was discovered during sampling of the five-pound bag product. Perrigo Issues Allergy Alert For Simple Truth Organic Banana, Strawberry & Apple Puree With Nonfat Greek Yogurt01/24/2019 Food RecallPerrigo Company, in coordination with The Kroger Company, is initiating a voluntary recall of one production lot of Simple Truth Organic Banana, Strawberry & Apple Fruit Puree with Nonfat Greek Yogurt (LOT L8159, best by 08/06/2019, produced in Spain) due to improper labeling that does not indicate the presence of milk, posing a potential risk to consumers with milk allergies. UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium and Hydrochlorothiazide Tablets, USP01/22/2019 Food RecallTorrent Pharmaceuticals Limited is expanding its voluntary recall from 10 lots of Losartan potassium tablets USP to include 6 lots of Losartan potassium and hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. Ottogi America, Inc. Issues Allergy Alert on Undeclared Egg in Products01/19/2019 Food RecallOttogi America, Inc. announced today it is recalling below 21 items due to a possibility of containing egg ingredient undeclared on the packages. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction of they consume these products. Prinston Pharmaceutical Inc. issues Voluntary Nationwide Recall of Irbesartan and Irbesartan HCTZ Tablets Due to detection of a Trace Amount of Unexpected Impurity, N- nitrosodiethylamine (NDEA) in the Products01/18/2019 Food Recall-- Prinston Pharmaceutical Inc., dba Solco Healthcare LLC., has initiated a voluntary recall of one (1) lot of Irbesartan and seven (7) lots of Irbesartan HCTZ Tablets to the consumer level due to the detection of trace amount of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. RXBAR Recalls Certain Varieties of Bars Due to a Potential Undeclared Peanut Allergen01/16/2019 Food RecallRXBAR is voluntarily recalling certain varieties of bars because they may contain undeclared peanuts. People who have peanut allergies run the risk of serious or life-threatening allergic reaction if they consume this product. Voluntary Recall Notice of El Guapo Chile Habanero and Chile Pasilla-Ancho Pouches Due to Unlabeled Peanut Allergen01/16/2019 Food RecallMojave Foods Corporation is initiating a voluntary recall of El Guapo Chile Habanero and Chile Pasilla-Ancho pouches due to an unlabeled peanut allergen. Happy Together, Inc. Issues Voluntary Nationwide Recall of Product Due to Presence of Undeclared Sildenafil and Tadalafil01/08/2019 Food RecallHappy Together, Inc. Boynton Beach, FL is voluntarily recalling all lots within expiry of the Rhino 5k capsules to the consumer level. FDA analysis founds these products to be tainted with sildenafil and Tadalafil. Sildenafil/Tadalafil is an FDA approved drug for the treatment of erectile dysfunction, the presence of sildenafil in the Rhino 5k products renders them unapproved drugs for which safety and efficacy have not been established, therefor subject to recall. Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of Vecuronium Bromide for Injection Due to the Presence of Particulate Matter Identified as Glass01/08/2019 Food RecallSun Pharmaceutical Industries, Inc. (SPII), a wholly owned subsidiary of Sun Pharmaceutical Industries, Ltd. is voluntarily recalling three lots of Vecuronium Bromide for Injection, 10 mg (lyophilized powder), and one lot of Vecuronium Bromide for Injection, 20 mg (lyophilized powder) to the hospital level. The Vecuronium Bromide for Injection has been found to contain particulate matter identified as glass. Grand Strand Sandwich Company Recalls Lunch Box Sandwiches Italian Subs Lunch Box Sandwiches Ham & Swiss Croissants And Lunch Box Sandwiches Ham & Cheese Due To Possible Listeria Monocytogenes Contamination01/08/2019 Food Recall– Grand Strand Sandwich is recalling Lunch Box Italian Subs, Lunch Box Ham & Swiss Croissants and Lunch Box Ham & Cheese Frozen Wedges due to a potential contamination of Listeria Monocytogenes. Hy-Vee Voluntarily Recalls Cheesecakes Made with Diamond Crystal Mix01/07/2019 Food RecallHy-Vee, Inc., based in West Des Moines, Iowa, is voluntarily recalling its cheesecakes made with Diamond Crystal Brands cheesecake mix due to the potential that they may be contaminated with Salmonella. The potential for contamination was brought to Hy-Vee’s attention today after receiving a letter from the supplier. The voluntary recall includes 32 varieties of cheesecakes in both 8-ounce and 32-ounce packages with best if used by dates of Dec. 6, 2018, through Jan. 11, 2019. No illnesses have been reported to date. Lupin Pharmaceuticals, Inc. Issues Voluntary Recall of Ceftriaxone for Injection USP, 250mg, 500mg, 1g and 2g01/05/2019 Food RecallLupin Pharmaceuticals, Inc. is voluntarily recalling 5 lots of Ceftriaxone for Injection, USP, 250mg, 10 lots of Ceftriaxone for Injection, USP, 500mg, 24 lots of Ceftriaxone for Injection, USP, 1g and 3 lots of Ceftriaxone for Injection, USP 2g, to the hospital/physician level. The products have been found to contain visual grey particulate matter in reconstituted vials. Olde York Potato Chips Issues Allergy Alert on Undeclared Milk in One Lot of Clancy's Wavy Potato Chips 10 Oz01/04/2019 Food RecallOlde York Potato Chips of Brampton, Ontario is recalling Clancy's Wavy Potato Chips 10 oz (UPC 0 41498 16306 8) with the specific lot code BEST If Used By FEB 22 19 1A6 because they may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products. No other lot codes and no other products are involved in this action. Shamrock Farms Issues Voluntary Recall of 2% Reduced Fat Vanilla Half Gallon Milk Due to Undeclared Almonds01/04/2019 Food RecallShamrock Farms of Phoenix, Arizona is issuing a voluntary recall of Shamrock Farms 2% Reduced Fat Vanilla Half Gallon Milk with Best Before Date 3/16/2019. The recall comes after a product retain of Shamrock Farms 2% Reduced Fat Vanilla Half Gallon Milk with Use By 03/16/19 Time Stamp 08:18-11:13 04-05 #1, tested positive for an undeclared tree nut (almond) allergen. Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP01/03/2019 Food RecallTorrent Pharmaceuticals Limited is expanding its voluntary recall from 2 lots of Losartan potassium tablets USP to a total of 10 lots, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. Torrent is only recalling lots of losartan-containing products that contain N-nitrosodiethylamine (NDEA) above the acceptable daily intake levels released by the FDA. Results RNA LLC Issues Voluntary Worldwide/Nationwide Recall of Lubrisine Eye Drops Due to Manufacturing Sterility Concerns and Undeclared Colloidal Silver01/03/2019 Food RecallResults RNA LLC is voluntarily recalling Lubrisine Eye Drops to the healthcare practitioner, retail or consumer level. This product, in a recent FDA inspection, was found to be manufactured using practices that do not support its sterility and contained undeclared colloidal silver. Oskri Organics Corporation Recalls Oskri Organic Sunflower Butter Lot #099, Oskri Tahini Butter Lot #193 and Thrive Sunflower Butter Lot #233 Because of Possible Health Risk01/02/2019 Food RecallOskri Organics Corporation of Lake Mills, WI is recalling Oskri Organic Sunflower Butter Lot # 099, Oskri Tahini Butter LOT # 193 and Thrive Sunflower Butter LOT # 233, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Consumer Level Recall of 80 Lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP, Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity01/01/2019 Food RecallAurobindo Pharma USA, Inc. is conducting a voluntary recall of 80 lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the finished drug product is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification. To date, Aurobindo Pharma USA, Inc. has not received any reports of adverse events related to this recall. Apio Inc. Expands Voluntary Recall of Eat Smart Salad Shake Ups Single-Serve Bowls12/26/2018 Food RecallApio Inc. of Guadalupe, California is expanding a voluntary recall of Eat Smart Salad Shake Ups single-serve bowls. The recall comes after the Canadian Food Inspection Agency (CFIA) informed the company that another random sample of Eat Smart Salad Shake Ups Sweet Kale/Chou Frise Doux 156 gr. single-serve bowls (5.5oz) with Best Before Date of Dec 29, 2018, Lot 112 346, tested positive for Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Columbia River Natural Pet Foods Inc. Voluntarily Expands Recall to Include Cow Pie and Chicken & Vegetables Fresh Frozen Meats for Dogs and Cats Due to Possible Health Risk12/24/2018 Food RecallColumbia River Natural Pet Foods of Vancouver, WA is voluntarily expanding their current recall to include additional products: 261 packages of Cow Pie Lot # 72618 and 82 packages of Chicken & Vegetables Lot# 111518 fresh frozen meats for dogs and cats, produced in July 2018 and November 2018, due to their potential to be contaminated with Salmonella and Listeria monocytogenes Funky Chunky, Llc Issues Allergy Alert on Undeclared Almond and Cashew Tree-Nut in 10 Oz. Nutty Choco Pop Found in Chocolate Popcorn Gift Box, Holiday Crowd Pleaser and Crowd Pleaser Gifts12/21/2018 Food RecallFunky Chunky, LLC of Eden Prairie, MN is recalling 10 oz Nutty Choco Pop Gift Box, 50 oz. Holiday Crowd Pleaser and 50 oz. Crowd Pleaser, because it may contain undeclared Almond and Cashew Tree Nut. People who have an allergy or severe sensitivity to Almonds and Cashews run the risk of serious or life-threatening allergic reaction if they consume these products. Inspired Organics Issues Voluntary Recall of Organic Nut & Seed Butters Due to Potential Health Risk12/20/2018 Food RecallInspired Organics, LLC has issued a voluntary recall of Organic Almond, Peanut, and Tahini Butters due to potential contamination of Listeria monocytogenes. Listeria monocytogenes is an organism, which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short- term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Terrific Care, LLC. / Medex Supply Dist, Inc. issues Nationwide Recall of CoaguChek Test Strips12/20/2018 Food RecallOn 12/19/2018, Terrific Care, LLC. / Medex Supply Dist, Inc. initiated a nationwide recall of Roche CoaguChek test strips distributed directly to U.S. consumers by Terrific Care, LLC. / Medex Supply Dist, Inc. The products have been found to inaccurately report high INR test results. Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP12/20/2018 Food RecallTorrent Pharmaceuticals Limited is voluntarily recalling 2 lots of Losartan potassium tablets, USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. The impurity detected in the API is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification. Fluoroquinolone Antibiotics: Safety Communication - Increased Risk of Ruptures or Tears in the Aorta Blood Vessel in Certain Patients12/20/2018 Medical RecallFDA review found that fluoroquinolone antibiotics can increase the occurrence of rare but serious events of ruptures or tears in the main artery of the body, called the aorta. These tears, called aortic dissections, or ruptures of an aortic aneurysm can lead to dangerous bleeding or even death. They can occur with fluoroquinolones for systemic use given by mouth or through an injection. Wegmans Issues Voluntary Recall of Fresh Cauliflower Rice, Veggie/Cauliflower Rice Blend and Stir-Fry Mix with Cauliflower12/19/2018 Food RecallRochester, NY – Wegmans Food Markets, Inc. has issued a voluntary recall of fresh Cauliflower Rice, Veggie Cauliflower Rice Blend and Stir-Fry Mix with Cauliflower, sold in the produce department between 12/7/18 and 12/18/18, because it may be contaminated with Escherichia coli O157:H7 bacteria (E. Coli O157:H7). E. coli O157:H7 causes a diarrheal illness often with bloody stools. Although most healthy adults can recover completely within a week, some people can develop a form of kidney failure called Hemolytic Uremic Syndrome (HUS). HUS is most likely to occur in young children and the elderly. The condition can lead to serious kidney damage and even death. Gilenya (fingolimod): Drug Safety Communication - Severe Worsening of Multiple Sclerosis After Stopping the Medicine11/20/2018 Medical RecallFDA is warning that when the multiple sclerosis (MS) medicine Gilenya (fingolimod) is stopped, the disease can become much worse than before the medicine was started or while it was being taken. This MS worsening is rare but can result in permanent disability. Implanted Pumps: Safety Communication - Use Caution When Selecting Pain Medicine for Intrathecal Administration11/14/2018 Medical RecallThe FDA is aware that patients undergoing treatment or management of pain are commonly given pain medicines in the spinal fluid (intrathecal administration) that are not FDA approved for use with the implanted pump. SGLT2(sodium-glucose cotransporter-2) Inhibitors for Diabetes: Drug Safety Communication - Regarding Rare Occurrences of a Serious Infection of the Genital Area08/29/2018 Medical RecallRequiring a new warning about this risk to be added to the prescribing information of all SGLT2 inhibitors and to the patient Medication Guide. Temporary Total Artificial Heart Companion 2 Driver System by SynCardia Systems: Letter to Health Care Providers - Risk of Mortality and Stroke08/17/2018 Medical RecallFDA has reviewed the final results from the post-approval study conducted by SynCardia Systems, LLC. for their Temporary Total Artificial Heart (TAH-t) Companion 2 Driver System (C2 Driver System). These final results indicate a higher mortality rate and higher stroke rate for patients initially supported with the C2 Driver System compared to patients initially supported with the previous generation driver, the Circulatory Support System (CSS) Console. Risks Associated with Use of Rupture of Membranes Tests - Letter to Health Care Providers08/08/2018 Medical RecallThe FDA is reminding health care providers that tests to detect rupture of the amniotic membranes should not be used without other clinical assessments to make critical patient management decisions. Zithromax, Zmax (azithromycin): FDA Warning - Increased Risk of Cancer Relapse With Long-Term Use After Donor Stem Cell Transplant08/03/2018 Medical RecallThe antibiotic Zithromax, Zmax (azithromycin) should not be given long-term to prevent a certain inflammatory lung condition in patients with cancers of the blood or lymph nodes who undergo a donor stem cell transplant. Results of a clinical trial found an increased rate of relapse in cancers affecting the blood and lymph nodes, including death, in these patients. Myocardial Protection System (MPS) Delivery Sets by Quest Medical: Recall - Intermittent Seal Failure During Use10/29/2015 Medical RecallSeal failure could result in patient blood loss. Auvi-Q (epinephrine injection, USP): Recall - Potential Inaccurate Dosage Delivery10/29/2015 Medical RecallIf a patient experiencing a serious allergic reaction (i.e., anaphylaxis) does not receive the intended dose, there could be significant health consequences, including death. Entacapone: Drug Safety Communication - FDA Review Found No Increased Cardiovascular Risks10/26/2015 Medical RecallDrug labels for Comtan and Stalevo will remain unchanged.
Hepatitis C Treatments Viekira Pak and Technivie: Drug Safety Communication - Risk of Serious Liver Injury10/22/2015 Medical RecallCases of hepatic decompensation and liver failure in patients with underlying liver cirrhosis who were taking these medicines. Alaris Medley Large Volume Pump (LVP) Frame Membrane by Elite Biomedical Solutions: Class I Recall - Frame Membrane May Allow Over or Under Delivery of Fluid by an Infusion Pump08/27/2015 Medical RecallOver or under infusion of fluids to the patient has the potential to cause patient injury or death. Picato (ingenol mebutate) Gel: Drug Safety Communication - FDA Warns of Severe Adverse Events, Requires Label Changes08/21/2015 Medical RecallSevere allergic reactions, skin rashes, & cases of shingles (herpes zoster reactivation) reported. Severe eye injuries and skin reactions have occurred when Picato gel is not applied according to recommendations in the label.
Implantable Left Ventricular Assist Devices (LVADs): FDA Safety Communication - Serious Adverse Events08/05/2015 Medical RecallIncreased rate of pump thrombosis, high rate of stroke, bleeding complications. HeartWare Ventricular Assist System Controllers by HeartWare International: Recall - Clinical Trial Controllers Susceptible to Electrostatic Discharge02/27/2015 Medical RecallElectrostatic discharge event could result in a pump stop, which could cause serious injury or death. The Cultured Kitchen Voluntarily Recalls Cashew Cheese Due To Possible Risk Of Contamination From Salmonella12/31/2013 Food RecallThe Cultured Kitchen of West Sacramento, CA is voluntarily recalling all flavors of their non-dairy cashew cheese product due to a risk of contamination from Salmonella. The non-dairy cashew cheese was distributed in Northern California and Nevada at various natural foods stores and farmers markets in the Sacramento Valley, San Francisco Bay Area, and Reno. PENTAX Medical Company Issues Voluntary Nationwide Recall of OF-B194 Gas/ Water Valve10/31/2013 Food RecallOn September 16, 2013 PENTAX Medical Company initiated a voluntary nationwide recall of 76 PENTAX Gas/ Water Valves, model OF-B194.The valves were offered as a separate purchase for use with PENTAX GI Video Endoscopes (90i/90k series and i10/k10 series).
Diabetes Treatments: FDA Alerts of Illegal Sales - Undeclared Ingredients07/23/2013 Medical RecallSome products may cause harm because they contain undeclared active drug ingredients or may not have been manufactured and handled according to FDA quality standards. Zyprexa Relprevv (Olanzapine Pamoate): Drug Safety Communication - FDA Investigating Two Deaths Following Injection06/18/2013 Medical RecallTwo patients died 3-4 days after receiving an appropriate dose of the drug. Posted 06/18/2013 |
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