Drug product
Clobetasol Propionate Cream, USP, 0.05%, packaged in a)15g Tubes (NDC 60429-902-15) and b) 45g Tubes (NDC 60429-902-45), Rx Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada, Marketed by: Golden State Medical Supply Inc. Camarillo, CA 93012.
D-1497-2020
Product summary
- Event
- Event 86129
- Status
- Terminated
- Classification
- Class III
- Quantity
- N/A
- Official record key
drug-enforcement:D-1497-2020
Official wording
Reason: Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.
Code information: Lot #: a) AB28535, Exp. Date: Dec. 2021 b) AB40178, Exp. Date: Dec. 2021
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Unknown
Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.