D-1496-2020 Class III Terminated
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