Recalls / Class II
Class IID-0676-2017
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
- Brand name
- Nystatin And Triamcinolone Acetonide
- Generic name
- Nystatin And Triamcinolone Acetonide
- Active ingredients
- Nystatin, Triamcinolone Acetonide
- Route
- Topical
- NDCs
- 51672-1263, 51672-1272
- FDA application
- ANDA062364
- Affected 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
Why it was recalled
Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability
Recalling firm
- Firm
- Taro Pharmaceuticals U.S.A., Inc.
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3 Skyline Dr, N/A, Hawthorne, New York 10532-2174
Distribution
- Quantity
- 278,304 tubes
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2017-03-28
- FDA classified
- 2017-04-20
- Posted by FDA
- 2017-04-26
- Terminated
- 2019-06-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0676-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.