FDA recall D-0676-2017

Taro Pharmaceuticals U.S.A., Inc. · Class II · drug

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

Distribution

Nationwide and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2017-03-28
Report date: 2017-04-26
Termination date: 2019-06-17
Voluntary/Mandated: Voluntary: Firm initiated
Location: Hawthorne, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0676-2017