FDAFDA · Food and drugs·Recall number D-0676-2017
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
Published April 26, 2017 · Recall initiated: March 28, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- NYSTATIN AND TRIAMCINOLONE ACETONIDE
- Manufacturer
- Taro Pharmaceuticals U.S.A., Inc.
- Distributor
- Nationwide and Puerto Rico
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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