FDA Enforcement and Recall Report Week of July 18

FDA Recalls

Each week the FDA reports on its enforcement activities as a guide to FDA compliance. To help capture and digest that information the FDA Atty blog will post FDA recalls and warning letters.

This week continues the slow roll out of recalls. The biggest burst coming from the continued E. Coli concern with General Mills.  Three of the 8 recalls posted related to the General Mills O121 issue that started about two weeks ago. This latest round captured companies using the flour in their own products. An additional three recalls related to undeclared allergens. A final two medical recalls rounded out the list for the week.

Warning letters are also lite with only two new postings. Both are for illegal drug residue in meat production animals. Although the USDA regulates the production of those animals, the FDA sets the thresholds on animal feed and medicated feeds. Both letters raise issues under this authority.

Recalls Week of July 18

07/15/2016 Rugby Diocto Liquid, docusate sodium solution Burkholderia cepacia contamination PharmaTech LLC
07/15/2016 Tippin’s Key Lime Pie Undeclared peanut Tippin’s Gourmet Pies, LLC
07/14/2016 Poppers Mozzarella Cheese Sticks Undeclared egg Monogram Appetizers, LLC
07/13/2016 Marie Callender’s Biscuit Mix E. coli O121 International Commissary Corporation
07/12/2016 Golden Dipt Jalapeno Breader E. coli O121 Kerry Inc.
07/12/2016 Snack Factory Pretzel Crisps Undeclared milk Baptista’s Bakery, Inc.
07/11/2016 Betty Crocker Cake Mix E. coli O121 General Mills
07/11/2016 Alere INRatio, Alere INRatio2 Monitoring System Patients with certain medical conditions should not be tested with the system Alere


Warning Letters Week of July 18

Letter Issue Date Company Name Issuing Office Subject Close Out Date
June 30, 2016 Morwai Dairy Denver District Office Illegal Drug Residue Not Issued *
June 28, 2016 Robin Martin Detroit District Office Illegal Drug Residue Not Issued *
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Marc Sanchez

Marc Sanchez

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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