Recalls / Class III
Class IIID-0249-2018
Product
Clobetasol Propionate Cream USP, 0.05% 60 g tube, Rx only Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761 Dist. by : Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532 UPC 351672125837 NDC 51672-1258-3
- Brand name
- Clobetasol Propionate
- Generic name
- Clobetasol Propionate
- Active ingredient
- Clobetasol Propionate
- Route
- Topical
- NDCs
- 51672-1258, 51672-1294, 51672-1259
- FDA application
- ANDA074249
- Affected lot / code info
- Lot 311235, exp Sept 2018
Why it was recalled
Failed Content Uniformity Specifications
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, Hawthorne, New York 10532-2174
Distribution
- Quantity
- 27,792 tubes
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-12-21
- FDA classified
- 2018-02-01
- Posted by FDA
- 2018-02-07
- Terminated
- 2020-09-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0249-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.