FDA Recalls / Safety Alerts

Drug major Pfizer has again expanded the earlier two recalls of its anti-smoking Drug Chantix (Varenicline) in the form of tablets, to now include all the lots, for the potential presence of nitrosamine impurity, N-Nitroso- varenicline, at or above the FDA interim acceptable intake limit (ADI), the U.S. Food and Drug Administration or FDA said in a statement.

Kroger Co. is recalling its 16-ounce Kroger bagged kale product, produced by Baker Farms, citing the possible contamination with Listeria Monocytogenes, a deadly bacteria, the U.S. Food and Drug Administration said. The recall includes 16-ounce bags of Kroger branded Kale, with the UPC 11110-18170 with a best by date of 09-18-2021.

Willard, Ohio-based Buurma Farms Inc. is recalling 320 boxes of its Plain Parsley citing possible contamination with Shiga-toxin producing E.coli, the U.S. Food and Drug Administration said. The recall involves Buurma Plain (flat leaf) Parsley with a harvest date of August 30, 2021 from their Gregory, Michigan location.

Seviroli Foods Inc. is recalling H-E-B Jumbo Stuffed Shells - 22 oz citing the potential presence of foreign material in product, the U.S. Foos and Drug Administration said. The Bellmawr, New Jersey-based company initiated the recall after H-E-B was notified of four customer complaints of metal presence in the product.

Monterey, California-based Dole Fresh Vegetables, Inc. is recalling a limited number of cases of conventional Curly Leaf Parsley citing possible contamination with non-O157 Shiga-Toxin producing E. coli, the U.S. Food and Drug Administration said.

Azurity Pharmaceuticals, Inc. is recalling one lot of Firvanq (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit to the consumer level due to a mix-up of the diluent, the U.S. Food and Drug Administration said. The company has distributed a total of 2,751 kits of the affected Firvanq, lot number 21035, with an expiration date of 2022-07-31.

ICU Medical, Inc., a pure-play infusion therapy company, is recalling one lot of Aminosyn II, 15%, An Amino Acid Injection, Sulfite Free intravenous or IV solution to the hospital/user level, the U.S. Food and Drug Administration said in a statement. The recall of 2,112 units of the amino acid injection was due to the presence of visible particulate matter identified as fibers, hair, and ...

Northbrook, Illinois-based Baking Institute Bakery Co. is recalling "Carrot Cake" citing the possible presence of undeclared allergens including walnuts, coconut, and milk, the U.S. Food and Drug Administration said. The affected product comes in a 6 inch and 8-inch round size and is packaged in a plastic container with a black base and a clear dome lid container.

Astoria, New York-based KBF Inc. is recalling its 8.11 ounce packages of "Banoful Top Orange Biscuit" food treats citing the possible presence of undeclared milk allergens, the U.S. Food and Durg Administration said. The recalled product comes in an 8.11 ounce, orange plastic package marked with MFG 15.06.2020 on the top and with an expiration date of 14/06/2022

Rocky Top Farms is recalling its 10-ounce jars of "Cherry Butter" fruit butter citing the possible presence of undeclared milk, a known allergen, the U.S. Food and Drug Administration announced. The product comes in a 10-ounce, clear glass jar. All lots are affected with the recall. The product may have been sold individually or in multi-packs or variety packs.

Cardinal Health Inc. has initiated a recall of around 267 million Monoject Flush Prefilled Saline Syringes (0.9% Sodium Chloride), the U.S. Food and Drug Administration announced. The products have been found to reintroduce air into the syringe after the air has been expelled. This could result in injection of air into blood vessels and create the potential for air embolism.

Hostess Brands, LLC is recalling certain Hostess Soft White Hamburger Buns and Soft White Hot Dog Buns citing potential to be contaminated with Listeria monocytogenes and Salmonella, the U.S. Food and Drug Administration said. The recall is limited to Hostess Soft White Hamburger Buns with UPC of 888109110987 and Soft White Hot Dog Buns with UPC of 888109110970 with various best by dates.

Drug major Pfizer has expanded its earlier recall of its Chantix (Varenicline) Tablets to include four additional lots, the U.D. Food and Drug Administration said. Chantix, a treatment to help patients quit smoking, has been recalled due to the presence of a nitrosamine impurity, N-nitroso-varenicline, above the established Acceptable Daily Intake or ADI level.

The U.S. Food and Drug Administration announced recall of various shrimp products, produced with shrimp supplied by Avanti Frozen Foods Pvt. Ltd, following the expansion of its initial recall, citing potential to be contaminated with Salmonella.The recalls were initiated after a multistate outbreak of Salmonella Weltevreden infections linked to the consumption of frozen cooked shrimp.

Clifton -based Jimmy's Cookies LLC is recalling LOT# 1133 Marketside Chocolate Candy Cookie Cake from certain Walmart stores for undeclared peanuts, the U.S. Food and Drug Administration said. The recall involves Marketside Chocolate Candy Cookie Cakes packed in a 12" x 12" container with a clear lid and a black and gold diamond label.