FDA recall D-0727-2022

Taro Pharmaceuticals U.S.A., Inc. · Class III · drug

Product

Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%,15 g tubes, Rx only, Manufactured by: Taro Pharmaceuticals Industries Ltd. Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4048-1

Reason for recall

Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample

Distribution

Product was distributed to one retail consignee in NY.

Key facts

Status: Terminated
Initiation date: 2022-02-25
Report date: 2022-04-06
Termination date: 2024-09-09
Voluntary/Mandated: Voluntary: Firm initiated
Location: Hawthorne, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0727-2022