December 2021 FDA Recall Clobetasol Propionate by Taro Pharmaceuticals U.s.a., Inc.
D-0375-2022 - Microbial Contamination of Non-Sterile Products
This Class I drug recall was voluntarily initiated by Taro Pharmaceuticals U.s.a., Inc. on December 15, 2021 for the product Clobetasol Propionate. The FDA reported the reason for recall as microbial contamination of non-sterile products. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0375-2022
Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria
12-15-2021
01-19-2022
96 tubes
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Taro Pharmaceuticals U.S.A., Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Two distributors in UT and LA who could have further distributed to the retail level nationwide in the USA.
12-04-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# AC13786, exp. date DEC 2022
