Recall: D-0375-2022

Class I - Dangerous

Class IClassification

2021-12-15Initiated

TerminatedStatus

Taro Pharmaceuticals U.S.A., IFirm

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

Reason

Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria

Distribution

Two distributors in UT and LA who could have further distributed to the retail level nationwide in the USA.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.