Recalls / Class III
Class IIID-0174-2023
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
- Brand name
- Clobetasol Propionate
- Generic name
- Clobetasol Propionate
- Active ingredient
- Clobetasol Propionate
- Route
- Topical
- NDC
- 68180-956
- FDA application
- ANDA210208
- Affected lot / code info
- Lot#: K101033; Exp 6/2024
Why it was recalled
Subpotent Drug: Low assay result observed during long-term stability testing.
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- Harborplace Tower, 111 S Calvert St Fl 21st, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- 5720 tubes
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2023-01-20
- FDA classified
- 2023-01-23
- Posted by FDA
- 2023-02-01
- Terminated
- 2024-01-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0174-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.