D-1496-2020 Class III Terminated

Recalled by Taro Pharmaceuticals U.S.A., Inc. — Hawthorne, NY

Recall Details

Product Type
Drugs
Report Date
August 19, 2020
Initiation Date
July 20, 2020
Termination Date
June 20, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7632 tubes

Product Description

Clobetasol Propionate Cream USP, 0.05%, a) 15 g tube, NDC: 60429-902-15; b) 45 g tube, NDC: 60429-902-45, Rx Only, For External Use Only, Not for Ophthalmic Use, Mfd by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1, Marketed by: Golden State Medical Supply, Inc. Camarillo, CA 93012.

Reason for Recall

Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.

Distribution Pattern

Nationwide in the U.S.

Code Information

a) AB28353, Exp 12/31/2021; b) AB40178, Exp 12/31/2021