Drug 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
D-0375-2022
Product summary
- Event
- Event 89241
- Status
- Terminated
- Classification
- Class I
- Quantity
- 96 tubes
- Official record key
drug-enforcement:D-0375-2022
Official wording
Reason: Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria
Code information: Lot# AC13786, exp. date DEC 2022
Distribution pattern: Two distributors in UT and LA who could have further distributed to the retail level nationwide in the USA.
Derived failure modes
-
Microbial contamination
Microbial Contamination