US Drug Recall Register
Class II · Moderate risk Terminated Initiated Mar 28, 2017 (9 years ago)

Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 USP nystatin units and 1 mg…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

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

Recalling firm
Taro Pharmaceuticals U.S.A., Inc.
NDC code
51672-1263-1
Origin
NY, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0676-2017

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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