Taro Pharmaceuticals U.S.A., Inc.: 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 gr

Is my product affected?

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, Onta

• Brand NYSTATIN AND TRIAMCINOLONE ACETONIDE

Check against the official notice below — it lists the full affected range.

What happened

Taro Pharmaceuticals U.S.A., Inc. is recalling nystatin and triamcinolone acetonide cream distributed nationwide and in Puerto Rico because the product failed content uniformity specifications and produced out-of-specification results during 18-month stability testing. The recall affects 278,304 tubes across multiple lot codes and sizes: 15-gram tubes from Lot B505118501 (expiration January 2018), 30-gram tubes from Lot B504918500 (expiration January 2018), and 60-gram tubes from Lots I416616979 and I416716979 (expiration August 2017) and Lot D504519119 (expiration March 2018).

The source document does not specify a remedy or instructions for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability Distribution: Nationwide and Puerto Rico Quantity: 278,304 tubes 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

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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