Recalls / Class I
Class ID-0375-2022
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. NDC 51672-1259-3
- 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# AC13786, exp. date DEC 2022
Why it was recalled
Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria
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
- 96 tubes
- Distribution pattern
- Two distributors in UT and LA who could have further distributed to the retail level nationwide in the USA.
Timeline
- Recall initiated
- 2021-12-15
- FDA classified
- 2022-01-18
- Posted by FDA
- 2022-01-19
- Terminated
- 2023-12-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0375-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.