FDA Enforcement and Recall Report Week of June 13

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

FDA Recalls – Allergen Recalls

Listeria continues to dominate the recall postings. A total of 15 new recall postings were posted. A full 10 of those were related to Listeria – 4 of those from one brand. It appears Listeria is continuing to drive the number of recalls. This is likely still tied to the CRF recall.  As the CRF recall continues to cool – this week will provide evidence of how many recalls remain – expect to see allergen recalls swing back to the top at some point.

An interesting recall linked to a dietary supplement spiked with Sibutramine. This is a common issue with weight loss dietary supplements. Other dietary supplement categories, like male enhancement supplements, are also commonly recalled due to undeclared drugs. As the FDA notes in the unrelated warning letter for a supplement with Subutramine “Sibutramine is the active pharmaceutical ingredient in Meridia, a new drug approved by FDA for marketing in 1997 for prescription treatment of obesity and, subsequently, withdrawn from the United States market on December 21, 2010 after clinical data indicated sibutramine poses an increased risk of heart attack and stroke.” Interesting that a Warning Letter and recall from two separate companies posted with the same issue.

FDA Warning Letters

This week 9 Warning Letters posted. The most interesting as noted above is the weight loss supplement with Sibutramine. This is GMP (identity, purity testing), labeling, and classification concerns all rolled into one. Two other warning letters focused on the classification issue, but neither involved the addition of undeclared active pharmaceutical ingredients (API). Other warning letters related to GMPs, QSR and labeling.

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

Recalls Week of June 13

06/10/2016 BOUNCE Protein Energy Balls Listeria monocytogenes Bounce USA
06/10/2016 nogii Nuts About Berries Paleo Bars Listeria monocytogenes NoGii
06/09/2016 DF Mavens Chocolate Almond Fudge Frozen Bars Undeclared Milk Fal Foods U.S.A. Inc.
06/08/2016 Multiple brands Sunflower Kernels, Sweet & Salty Mix and Cajun Hot Mix Listeria monocytogenes Rucker’s Wholesale and Service Co
06/08/2016 Stuckey’s Sunflower Kernels Listeria monocytogenes Taylor’s Candy, Inc.
06/08/2016 Nature Made Adult Gummies and Tablets Salmonella and Staphylococcus aureus Pharmavite LLC
06/07/2016 Market District Sunflower Seeds Listeria monocytogenes Giant Eagle
06/07/2016 Market District Sunflower Seeds Listeria monocytogenes Giant Eagle
06/07/2016 Market District Sunflower Seeds Listeria monocytogenes Giant Eagle
06/07/2016 Market District Sunflower Seeds Listeria monocytogenes Giant Eagle
06/07/2016 Step 2 Dietary Supplement Undeclared Sibutramine; Unapproved New Drug The Body Shot Bar
06/07/2016 Dollywood Cajun Mix Listeria monocytogenes Rucker’s Makin’ Batch Candies, Inc
06/06/2016 Rold Gold Pretzels Undeclared Peanut Frito-Lay
06/06/2016 SoFit Sunflower seeds, Pumpkin seeds, Almonds Listeria monocytogenes The Hershey Company
06/06/2016 Waffle Works Double Chocolate Waffle Sandwiches Undeclared Milk Herr Foods Inc.

Warning Letters Week of June 13

May 27, 2016 Ko Da Pharmaceutical Co Ltd Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
May 23, 2016 Spectranetics Corporation Denver District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
May 19, 2016 RXQ Compounding LLC Cincinnati District Office Unapproved New Drug/Compounding/Misbranding/Adulterated Not Issued *
May 06, 2016 Sweet Production Inc. San Francisco District Office Food Labeling/Misbranded Not Issued *
March 14, 2016 Liberty Drug & Surgical New Jersey District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
June 01, 2016 86 Harriet Ave Corporation DBA General Devices New Jersey District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
April 14, 2016 Hollywood Skincare International Inc. Florida District Office Unapproved New Drugs/Misbranded June 01, 2016
April 14, 2016 Ultimate Weight Loss Co. Florida District Office Unapproved New Drugs/Misbranded Not Issued *
April 12, 2016 Florida Institute for Reproductive Sciences and Technologies Florida District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) 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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