FDA Recall D-0375-2022
Taro Pharmaceuticals U.S.A., Inc. · Hawthorne, NY
Class I — life-threatening Terminated 719 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence 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
Reason for recall
Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria
Recall record
- Recall number
D-0375-2022- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Two distributors in UT and LA who could have further distributed to the retail level nationwide in the USA.
- Recall initiated
- 2021-12-15
- Classified by FDA Center
- 2022-01-18
- FDA published
- 2022-01-19
- Terminated
- 2023-12-04
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
- Firm location
- Hawthorne, NY
Drug identification
- Brand name(s)
- CLOBETASOL PROPIONATE
- Generic name(s)
- CLOBETASOL PROPIONATE
- Manufacturer(s)
- Sun Pharmaceutical Industries, Inc.
- NDC(s)
51672-1258, 51672-1294, 51672-1259- Route(s)
- TOPICAL