D-0375-2022 Class I Terminated

Recalled by Taro Pharmaceuticals U.S.A., Inc. — Hawthorne, NY

Recall Details

Product Type
Drugs
Report Date
January 19, 2022
Initiation Date
December 15, 2021
Termination Date
December 4, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
96 tubes

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

Distribution Pattern

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