Drug product
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.
D-1496-2020
Product summary
- Event
- Event 86101
- Status
- Terminated
- Classification
- Class III
- Quantity
- 7632 tubes
- Official record key
drug-enforcement:D-1496-2020
Official wording
Reason: Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.
Code information: a) AB28353, Exp 12/31/2021; b) AB40178, Exp 12/31/2021
Distribution pattern: Nationwide in the U.S.
Derived failure modes
-
Unknown
Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.