FDA recall D-0375-2022

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 for recall

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.

Key facts

Status

Terminated

Initiation date

2021-12-15

Report date

2022-01-19

Termination date

2023-12-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hawthorne, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0375-2022