Drug product
Clobetasol Propionate Foam, 0.05%, packaged in a) 50 g can (NDC 50742-304-50), and b) 100 g can (NDC 50742-304-01), Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL 32839-6408.
D-0374-2022
Product summary
- Event
- Event 89393
- Status
- Terminated
- Classification
- Class II
- Quantity
- 45,173 cans
- Official record key
drug-enforcement:D-0374-2022
Official wording
Reason: CGMP Deviations
Code information: a) Lots: 32921 Exp. 06/2022; 33152 Exp. 08/2022; 33340 Exp. 11/2022; b) Lots: 33152 Exp. 08/2022; 33340 Exp. 11/2022.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations