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.
Category Archives: Food & Drug Recalls
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.
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The U.S. Food and Drug Administration today issued a draft guidance that outlines the agency’s recommendations and procedures for medical device manufacturers and researchers who want early feedback and advice before submitting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.
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.
Stryker Initiates Voluntary Product Recall of Modular-Neck Stems Action Specific to Rejuvenate and ABG II Modular-Neck Stems
Stryker has voluntarily recalled its Rejuvenate and ABG II modular-neck stems. “While modular-neck stems provide surgeons with an option to correct certain aspects of a patient’s anatomy and hip biomechanics, given the potential risks associated with fretting and corrosion at the modular neck junction, Stryker Orthopaedics decided to take this voluntary action,” said Stuart Simpson, Vice President and General Manager, Hip Reconstruction.
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.
Cass-Clay Creamery Issues Allergy Alert on Undeclared Eggs in Peppermint Bon Bon Ice Cream
Cass-Clay Creamery of Fargo, N.D., is voluntarily recalling Hornbacher's Peppermint Bon Bon Light (half gallon/1.89 liter), Schroeder Peppermint Bon Bon (1.75 quart/1.65 liter) and SunnyBrook Peppermint Bon Bon Light (half gallon/1.89 liter) because they may contain undeclared eggs. 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.
Expanded Voluntary Recall of Mazuri® Feed Products Due to Potential Elevated Vitamin D Level
PMI Nutrition International is expanding a voluntary recall to include three additional varieties of the Mazuri feed products listed below, due to the potential for an elevated vitamin D level in these products. Elevated vitamin D levels can be harmful to animals if fed for extended periods, and may result in lack of interest in eating, weight loss and possible joint stiffness.