Reported Apr 26, 2017 · Terminated
Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 USP nystatin units and 1 mg triamcinolone acetonide,…
Taro Pharmaceuticals U.S.A., Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Taro Pharmaceuticals U.S.A., Inc. · 3 Skyline Dr · Hawthorne, NY · 10532-2174
Is this the product you have?
3 of 3 products
| # | Product as published |
|---|---|
| 1 | 15 grams (NDC 51672-1263-1) |
| 2 | 30 grams (NDC 51672-1263-2) and |
| 3 | 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 |
- Lot codes and dates
- a) 15 g
Lot B505118501exp. date January 2018
- b) 30 g
Lot B504918500exp. date January 2018
- c) 60 g
Lots: I416616979exp. date August 2017I416716979exp. date August 2017 and D504519119exp. date March 2018
- a) 15 g
- Amount recalled
- 278,304 tubes
Where it was sold
- Nationwide
- PR
Why it was recalled
Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability
This product could cause temporary or reversible health problems — stop using it.
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