Drug recall D-0676-2017
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
Reason for recall
Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability
Lots and codes
a) 15 g: Lot B505118501, exp. date January 2018; b) 30 g: Lot B504918500, exp. date January 2018; c) 60 g: Lots: I416616979, exp. date August 2017, I416716979, exp. date August 2017 and D504519119, exp. date March 2018
Recall details
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY
- Quantity
- 278,304 tubes
- Distribution
- Nationwide and Puerto Rico
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 28, 2017
- Terminated
- June 17, 2019
Related products
- Nystatin and Triamcinolone Acetonide – drug information
- NDC 51672-1263 Nystatin and Triamcinolone Acetonide · Nystatin 100000 [USP'U]/g; Triamcinolone Acetonide 1 mg/g · Sun Pharmaceutical Industries, Inc.
- NDC 51672-1272 Nystatin and Triamcinolone Acetonide · Nystatin 100000 [USP'U]/g; Triamcinolone Acetonide 1 mg/g · Sun Pharmaceutical Industries, Inc.