Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro Pharmaceutical Indus...
FDA Recall #D-0375-2022 — Class I — December 15, 2021
Product Description
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
Recalling Firm
Taro Pharmaceuticals U.S.A., Inc. — Hawthorne, NY
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
96 tubes
Distribution
Two distributors in UT and LA who could have further distributed to the retail level nationwide in the USA.
Code Information
Lot# AC13786, exp. date DEC 2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated