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
Reported: February 1, 2023 Initiated: January 20, 2023 #D-0174-2023
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.
Details
- Recalling Firm
- Lupin Pharmaceuticals Inc.
- Units Affected
- 5720 tubes
- Distribution
- USA Nationwide
- Location
- Baltimore, MD
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 5720 tubes.
Why was this product recalled? ▼
Subpotent Drug: Low assay result observed during long-term stability testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 1, 2023. Severity: Low. Recall number: D-0174-2023.
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