Drug product
Clobetasol propionate Cream USP, 0.05%, 45 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC 68180-956-03
D-0174-2023
Product summary
- Event
- Event 91532
- Status
- Terminated
- Classification
- Class III
- Quantity
- 5720 tubes
- Official record key
drug-enforcement:D-0174-2023
Official wording
Reason: Subpotent Drug: Low assay result observed during long-term stability testing.
Code information: Lot#: K101033; Exp 6/2024
Distribution pattern: USA Nationwide
Derived failure modes
-
Potency or specification failure
Subpotent