PlainRecalls
FDA Drug Critical Class I Terminated

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

Reported: January 19, 2022 Initiated: December 15, 2021 #D-0375-2022

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

Details

Units Affected
96 tubes
Distribution
Two distributors in UT and LA who could have further distributed to the retail level nationwide in the USA.
Location
Hawthorne, NY

Frequently Asked Questions

What product was recalled?
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. Recalled by Taro Pharmaceuticals U.S.A., Inc.. Units affected: 96 tubes.
Why was this product recalled?
Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria
Which agency issued this recall?
This recall was issued by the FDA Drug on January 19, 2022. Severity: Critical. Recall number: D-0375-2022.