Taro Pharmaceuticals U.S.A., Inc. recalls Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 USP nystatin units and 1 mg triamcinolone acetonide, distribut…

Recall date

March 28, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0676-2017

FDA classification

Class II

Brand / firm

Taro Pharmaceuticals U.S.A., Inc.

Sold / distributed

Nationwide and Puerto Rico

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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