The U.S. Food and Drug Administration is seeking an injunction requiring Kabco Pharmaceuticals Inc., and owner Abu Kabir, of Amityville, N.Y., to stop producing and distributing dietary supplements until they comply with the Federal Food, Drug and Cosmetic Act and current good manufacturing practice (cGMP) requirements for dietary supplements.
FDA warns consumers about Listeria threat in Mexicali Cheese Corp. products
The U.S. Food and Drug Administration is warning consumers not to purchase or consume any products from the Mexicali Cheese Corp. of Woodhaven, N.Y., after the bacterium Listeria monocytogenes was found in the company’s finished product.
Voluntary Recall of Purina Products Due to Potential Elevated Vitamin D Level
Land O’Lakes Purina Feed LLC has initiated a voluntary recall of specific lots of Purina® feed products listed below, due to the potential for elevated vitamin D levels. Elevated vitamin D levels may cause death or otherwise be harmful to animals and fish if fed for extended periods, potentially resulting in lack of interest in eating, weight loss and possible joint stiffness.
Westone Laboratories Inc. Issues Voluntary Nationwide Recall of all sizes and packaging configurations of Oto-Ease ear lubricant due to possible microbial contamination.
Westone Laboratories, Inc. is initiating a
voluntary nationwide recall of all sizes and packaging configurations of Oto-Ease® ear
lubricant. The products have been found through a consumer complaint and the U.S. Food
and Drug Administration (FDA) sample analysis to be potentially contaminated with
pathogenic bacteria and mold.
FDA outlines plans to provide earlier feedback on device product submissions
The U.S. Food and Drug Administration today issued a draft guidance that outlines the agency’s recommendations and procedures for medical device manufacturers and researchers who want early feedback and advice before submitting a product- or research-specific application.
FDA, UC Davis, Agilent Technologies and CDC to create publicly available food pathogen genome database
The U.S. Food and Drug Administration (FDA), the University of California, Davis, Agilent Technologies Inc., and the Centers for Disease Control and Prevention (CDC) announced today a collaboration to create a public database of 100,000 foodborne pathogen genomes to help speed identification of bacteria responsible for foodborne outbreaks.
Wisconsin livestock dealer enters into consent decree involving drug residues in cows
A Wisconsin livestock company and its owner have entered into a consent decree of permanent injunction resulting from a complaint filed by the U.S. Department of Justice on behalf of the FDA alleging violations of federal food and drug safety requirements.
Winn-Dixie Issues Class II Recall On Winn-Dixie Brand Cheeseburger Macaroni Skillet Dinner
Winn-Dixie today announced an immediate Class II voluntary recall of Winn-Dixie Cheeseburger Macaroni Skillet Dinners sold in the 5.8 oz. package with a UPC code of 2114018080, and a sell-by date of May 14, 2013. According to the Food & Drug Administration (FDA), the reason for the recall is the potential for the product to contain small metal fragments.
FDA introduces new safety measures for extended-release and long-acting opioid medications
The U.S. Food and Drug Administration today approved a risk evaluation and mitigation strategy (REMS) for extended-release (ER) and long-acting (LA) opioids, highly potent drugs approved for moderate to severe, persistent pain that requires treatment for an extended period.
Sedona Labs Issues A Voluntary Recall For iFlora Kids Multi-Probiotic And iFlora 4-Kids Powder Dietary Supplements Due To Possible Health Risk
Sedona Labs today announced that its supplier of Galactooligosaccharide (GOS) has recalled this ingredient due to a possible Salmonella contamination. As a result, we are now voluntarily recalling certain lots of our iFlora Kids Multi-Probiotic and iFlora 4-Kids Powder distributed between 3/16/2011 and 5/3/2012.