Category Archives: Food & Drug Recalls

University Compounding Pharmacy Initiates a Nationwide Voluntary Recall of Certain Pharmacy Products due to Lack of Assurance of Sterility Concerns

University Compounding Pharmacy is voluntarily recalling the following preparations (see below) for injection, to the consumer level. In a recent inspection, FDA investigators observed that methods used by the Independent Third Party laboratory to assess sterility may have resulted in pharmacies receiving inaccurate laboratory test results. FDA has concerns that results obtained from the laboratory are not reliable.

Updated Press Release: GoPicnic Brands Announces Voluntary Recall of Limited Quantity Vegan Meals Due to Undeclared Milk Allergen

GoPicnic Brands, Inc. is voluntarily recalling two vegan ready-­‐to-­‐ eat meals, GoPicnic Black Bean Dip & Plantain Chips and Hummus & Crackers, containing Professor Zim Zam’s Extraordinary Sweets Dark Chocolate with Orange and Dark Chocolate with Sea Salt. The chocolate products in these meals may contain an undeclared milk allergen.

McNeil Consumer Healthcare Announces Voluntary Recall of Three Lots of Concentrated MOTRIN Infants Drops Original Berry Flavor 1/2 fl oz.

McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. (“McNeil”) is voluntarily recalling at the retail level three lots, approximately 200,000 bottles, of Concentrated MOTRIN® Infants’ Drops Original Berry Flavor 1/2 fl oz bottles distributed in the United States (see full product list below). This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).

Cains Foods Issues an Allergen Alert for Undeclared Milk and Egg in Olde Cape Cod Chipotle Ranch Dressing

Cains Foods is recalling 2,273 six-pack cases of 16 oz. Olde Cape Cod Chipotle Ranch dressing with a “Best By” date of Nov. 30, 2014 because it may contain undeclared milk and egg. People who have allergies to milk and egg run the risk of serious or life-threatening reactions if they consume products containing these ingredients.
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Medaus Pharmacy Initiates a Nationwide Recall of Certain Pharmacy Products due to Questions Surrounding an Independent Third Party’s Sterility Testing

Medaus Pharmacy is voluntarily recalling certain sterile compounded consumer products (see table) due to our inability to confirm that the quality control testing performed on these specific lots by an independent, third party laboratory was conducted in a manner consistent with the highest standards of excellence we demand from ourselves and on behalf of our patients. Though Medaus received test results indicating that these lots met all safety standards, they are being recalled because the independent testing lab’s sterility testing practices as applied to these lots indicate that the product’s sterility cannot be confirmed.

Hubbard Feeds Inc. Announces an Expanded Voluntary Recall of Hubbard Life Homestead FastGrow Poultry Feed in Indiana, Michigan and Illinois Due to Elevated Calcium

Hubbard Feeds Inc. announced today a voluntary recall of three additional lots of Hubbard Life Homestead FASTGROW AM.0.0125 NAB/NAB MEDICATED because of elevated calcium levels that may be harmful to chickens and turkeys. This voluntary recall is the result of identification of additional lot numbers through assays by the FDA related to a voluntary recall of the same product on July 2, 2013. No adverse events or complaints have been reported to date for the three additional lots listed below.

Federal judge approves consent decree against Dakota Laboratories

Dakota Laboratories LLC and its president, Charles L. Voellinger, Sr., are prohibited from manufacturing and distributing drugs until they correct their ongoing violations of the drug manufacturing laws. The U.S. Food and Drug Administration entered into a consent decree of permanent injunction on Aug. 26, 2013 which enjoined the drug maker and distributor for repeated failure to comply with federal drug manufacturing requirements, known as Current Good Manufacturing Practices (cGMPs).

Premier Foods, LLC Announces The Recall Of Products Sold At Williams-Sonoma For Undeclared Allergens

Premier Foods, LLC of Santa Fe Springs, CA is voluntarily recalling four flavored sauces due to the failure to declare the following allergens on the product labels: milk, soy, and/or wheat. The products were sold at Williams-Sonoma. People who have allergies to milk, soy, and/or wheat run the risk of serious or life-threatening reactions if they consume products containing these ingredients. 

Hospira Issues A Voluntary Nationwide Recall Of One Lot Of Aminosyn II 10 percent, Sulfite-Free, Due To Foreign Particulate Matter

Hospira, Inc. announced today it is initiating a voluntary nationwide user-level recall of one lot of Aminosyn II 10 percent, Sulfite-Free, 500mL, NDC 0409-4164-03 Lot 26-138-JT. This action is due to one confirmed customer report where an unknown foreign particle was included in the injection port and in contact with product. The foreign particle was confirmed by Hospira as human hair. To date, Hospira has not received reports of any adverse events associated with this issue for this lot. This recall is being conducted as a precautionary measure.