Recall: D-0174-2023

Class III - Minor Violations

Class IIIClassification

2023-01-20Initiated

TerminatedStatus

Lupin Pharmaceuticals Inc.Firm

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

Reason

Subpotent Drug: Low assay result observed during long-term stability testing.

Distribution

USA Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.