Drug product
Clobetasol Propionate Foam (Emulsion Formulation), 0.05% a) 50 g pack (NDC 68462-625-27) and b) 100 g pack (NDC 68462-625-94), Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited Plot No. B-25, MIDC, Shendra Aurangabad, Maharashtra -431210, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
D-0619-2020
Product summary
- Event
- Event 84282
- Status
- Terminated
- Classification
- Class III
- Quantity
- a) 480 packs; b) 240 packs
- Official record key
drug-enforcement:D-0619-2020
Official wording
Reason: Defective delivery system; product is not foaming or is coming out as liquid.
Code information: Lot 14190067, exp Jul-2021
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Defective delivery system; product is not foaming or is coming out as liquid.