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in Meridia, a new drug approved by FDA for marketing in 1997 for prescription treatment of obesity and, subsequently, withdrawn from the United States market on December 21, 2010 after clinical data indicated sibutramine poses an increased risk of heart attack and stroke.”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.

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Recalls Week of June 13

Warning Letters Week of June 13