Class II Terminated

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

Company: Taro Pharmaceuticals U.S.A., Inc.
Recall Initiated: March 28, 2017
Posted: April 26, 2017
Recall Number: D-0676-2017
Voluntary / Mandated: Voluntary: Firm initiated
Quantity: 278,304 tubes
Firm Location: Hawthorne, NY, United States

Reason for Recall

Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability

Distribution

Nationwide and Puerto Rico

Lot / Code Info

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

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View all recalls by this company →

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