Taro Pharmaceuticals U.S.A., Inc. recalls Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 USP nystatin units and 1 mg triamcinolone acetonide, distribute
Recalled April 26, 2017 · FDA recall D-0676-2017 · Taro Pharmaceuticals U.S.A
Hazard
Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability · FDA Class II
Units
278,304 tubes
Sold at
Nationwide and Puerto Rico
Description
Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability
Product
Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 USP nystatin units and 1 mg triamcinolone acetonide, distributed in a) 15 grams (NDC 51672-1263-1), b) 30 grams (NDC 51672-1263-2) and c) 60 grams (NDC 51672-1263-3) tubes, Rx only, TARO label; Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1 -- Dist. by: Taro Pharmaceuticals U.S.A. Inc., Hawthorne, NY 10532
Manufacturer(s)
Taro Pharmaceuticals U.S.A., Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →