D-0174-2023 Class III Terminated
FDA drug recall D-0174-2023 was initiated by Lupin Pharmaceuticals Inc. on January 20, 2023 and is designated Class III. Reason for recall: Subpotent Drug: Low assay result observed during long-term stability testing. The recall status is terminated (terminated January 16, 2024). Affected quantity: 5720 tubes.
Recall Details
- Product Type
- Drugs
- Report Date
- February 1, 2023
- Initiation Date
- January 20, 2023
- Termination Date
- January 16, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5720 tubes
Product Description
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
Reason for Recall
Subpotent Drug: Low assay result observed during long-term stability testing.
Distribution Pattern
USA Nationwide
Code Information
Lot#: K101033; Exp 6/2024