Alvogen is voluntarily recalling seven lots of Clindamycin Injection USP ADD-Vantage Vials to the hospital/retail level due to microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the product. Clindamycin Injection is manufactured for Alvogen by Hospira Inc., a Pfizer Company.
Vitakraft Sun Seed Inc. of Weston, OH, is voluntarily recalling certain Sunseed Parrot Fruit & Vegetable diet and Sunseed SunSations Rabbit Food due to a potential Listeria monocytogenes contamination. 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. […]
Chic-a-Peas, LLC is voluntarily recalling a limited number of Chic-a-Peas Baked Crunchy Chickpeas 2 oz. packages because the product 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 […]
Willis Ocean Inc., Brooklyn, NY, is recalling its “the duck” brand “frozen steamed scomber fish”, because the product was found to be uneviscerated. The steamed scomber fish were distributed nationwide through retail stores. Read The Complete Story!
NOW Health Group, Inc. (NOW), of Bloomingdale, Illinois, is expanding the voluntary recall of Ellyndale® Nutty Infusions™ Roasted Cashew Butter – Product Code E0540, Lot# 2125155, and Ginger Wasabi Cashew Butter — Product Code E0541, Lot# 2124118, to include Roasted Almond Butter – Product Code E0545, Lot# 2124119, and Mango Chili Cashew Butter – Product […]
Hospira, Inc., a Pfizer company, is voluntarily recalling 42 lots of 8.4% Sodium Bicarbonate Injection, USP, 50 mL vials, 5 lots of NeutTM (Sodium Bicarbonate 4% additive solution) 5 mL vials, 5 lots of QUELICINTM (Succinylcholine Chloride Injection, USP) 200 mg/10 mL vials and 7 lots of Potassium Phosphates Injection, USP, 45 mM vials to […]
Advanced Pharma, Inc. d/b/a Avella of Houston (“Advanced Pharma”) is voluntarily recalling all unexpired lots of Nitroglycerin products that were produced at Advanced Pharma’s Houston location between March 3, 2017 and May 31, 2017 to the hospital/user level. The recall is being issued based on laboratory test results indicating a lower than expected potency on […]
NEW ENGLAND NATURAL BAKERS of Greenfield MA, is issuing a voluntary recall, the company has been notified by an ingredient supplier that an ingredient used in these products has the potential to be contaminated with Listeria monocytogenes.
Teva Pharmaceuticals USA, Inc. (Teva) initiated a voluntary recall to retail-level on 05/31/2017 for one lot of Paliperidone Extended-Release Tablets, 3mg, 90 count bottles that was distributed under the Actavis Pharma Inc. label. In coordination with FDA, Teva is extending this recall to the CONSUMER/USER level.
While the latest numbers from the 2016 National Youth Tobacco Survey are encouraging, it is critical that we work to ensure this downward trend continues over the long term across all tobacco products. Every day in the U.S., more than 2,500 youth under the age of 18 smoke their first cigarette and more than 400 […]
Today, U.S. District Judge Kathleen M. Williams for the Southern District of Florida entered a consent decree of permanent injunction between the United States and Stratus Pharmaceuticals Inc. of Miami, Florida, Sonar Products Inc. of Carlstadt, New Jersey and two of the companies’ officers, Alberto Hoyo and Juan Carlos Billoch.
The Kroger Co. (NYSE: KR) today announced it has expanded the recall of its 12 oz. packages of Simple Truth Dry Roasted Macadamia Nuts due to potential Listeria monocytogenes contamination. 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 […]
GoMacro, of Viola, Wis., is recalling a limited number of MacroBars and Thrive Bars 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 […]
– Bulletproof 360, Inc. (“Bulletproof”) of Bellevue, Washington is recalling five Collagen Protein Bar and Bite products 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.
Wildway LLC is voluntarily recalling certain grain-free granola codes, because the Company has been notified by an ingredient supplier that an ingredient used in these products has the potential to be contaminated with Listeria monocytogenes.
Loving Pets of Cranbury, NJ is voluntarily recalling a limited number of dog treats because of the potential to be contaminated with Salmonella. Salmonella can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the […]
Phillips Company is voluntarily recalling all lots of Tetrastem, Diabecline, Tetracycline-ABC, VenomX, Acneen, StaphWash, StringMed, NoPain and LidoMed distributed by Phillips Company, with business offices located in Sun City, Arizona, to the retail level. The products are being recalled after an FDA inspection found significant manufacturing practices that calls into question the safety, identity, strength, […]
Bristol-Myers Squibb Company (NYSE: BMY) is voluntarily recalling one lot (#HN0063) of Eliquis 5 mg tablets to the consumer level. This lot was distributed nationwide in the U.S. to wholesalers and retail pharmacies in February 2017. Bristol-Myers Squibb is taking this precautionary measure based on a customer complaint that a bottle labeled as Eliquis 5 […]
Last month, I asked my colleagues at the FDA to identify what additional and more forceful steps the FDA can take, on top of the vigorous work the agency is already doing, to address the crisis of opioid addiction. Everyone at the FDA is committed to focusing on all aspects of the epidemic. The new […]