FDA Enforcement and Recall Report Week of April 11

FDA Enforcement and Recall Report Week of April 11

Each week the FDA reports on its enforcement activities. To help capture and digest that information starting this week the FDA Atty blog will post FDA recalls and warning letters.

FDA Recalls

This past week the FDA posted 14 recall notices. Those notices are posted below. The FDA recall notices continue to show undeclared allergens as the leading cause of recall. A total of 6, or 50%, of the notices involve undeclared allergens. This will be an area of increased enforcement under FSMA’s allergen controls (see Food Safety Modernization Act; HARPC Rule).

One FDA recall notice included a dietary supplement containing pharmaceutical ingredients. This is a common quality issue for weight loss and male enhancement supplements.

The remaining FDA recall notices involved drug and device GMP issues and Herring oil that may contain Listeria.

FDA Warning Letters post weekly but generally are issued earlier than posted. The most recent FDA Warning Letters involve 4 Center for Tobacco Retailer warning letters. Warning Letters issued for violations of the Family Smoking Prevention and Tobacco Control Act are among the most common. Other FDA Warning Letters include an Institutional Review Board that inadequately followed protocols as reflected in a FDA Form 483.

The FDA also issued a Warning Letter for an unapproved device. This is a common scenario where a product enters the market without completing the appropriate reviews to determine if the product is a medical device and what pre-market pathway would then be required.

Please contact our Washington D.C. or Charlotte NC office with any FDA recall, Warning Letter or other enforcement questions.

FDA Recalls April 10-14

04/14/2016 Norven Herring in oil Listeria monocytogenes OLMA-XXI Inc.
04/14/2016 Sugarfina Milk Chocolate Malt Balls Undeclared peanuts Sugarfina LLC
04/14/2016 Thomas’ Buns Bread Undeclared milk and eggs Thomas Star Bakery of Ohio
04/14/2016 Gorgeous Memory (Dried) Daylily Undeclared Sulfites A&S Food Trading Inc.
04/13/2016 Hospira 50% Magnesium Sulfate Injection, USP Particulate Matter Hospira, Inc.
04/11/2016 Whole Foods Market Asparagus, Pea & Ricotta Salad Undeclared Egg Whole Foods Market
04/11/2016 Dexcom Dexcom G4 Platinum Receivers, Dexcom G4 Platinum Pediatric Receivers, Dexcom G4 Platinum Professional Receivers, Dexcom G4 Platinum with Share Receivers, Dexcom G4 Platinum with Share Pediatric Receivers and the Dexcom G5 Mobile Receivers Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert. Dexcom, Inc.
04/11/2016 Back to Nature Classic Crème Cookies Undeclared Milk Back to Nature Foods, LLC
04/11/2016 Vascular Solutions Guardian® II Hemostasis Valves Because they pose an increased risk of air leakage that may lead to an air embolism. Vascular Solutions, Inc.
04/11/2016 PICs by Price Chopper Cinnamon Rolls with Cream Cheese Icing Undeclared Milk EBB U.S. Inc. (English Bay Batter)

 

04/11/2016 Super Herbs Super Herbs Capsules, Weight Loss Dietary Supplement Unapproved new drug- FDA laboratory testing found SUPER HERBS to contain sibutramine, desmethylsibutramine, and/or phenolphthalein. Super Herbs
04/10/2016 Various: Reser’s, Stonemill Kitchens, Safeway, Walmart Various salads: potato salad, macaroni salad, deviled egg potato salad, tuna salad. Listeria monocytogenes Reser’s Fine Foods, Inc.

FDA Warning Letters as of 4/18/16

March 30, 2016 Tobacco Depot LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
March 30, 2016 www.domino.be Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
March 30, 2016 www.dutyfree.io Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
March 30, 2016 www.smokerlink.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
March 17, 2016 Miami Fat Supply, Inc Florida District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
March 01, 2016 Pikeville Medical Center Inc., Institutional Review Board Center for Drug Evaluation and Research Institutional Review Board (IRB) Not Issued *
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Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation. He represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries.

Marc is the author of two textbooks and a lecturer at Northeastern University. He is a member of the Washington State Bar Association and the D.C. Bar Association.

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