Drug recall D-0174-2023

Class III Terminated reported Feb 1, 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

Reason for recall

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

Lots and codes

Lot#: K101033; Exp 6/2024

Recall details

Recalling firm
Lupin Pharmaceuticals Inc., Baltimore, MD
Quantity
5720 tubes
Distribution
USA Nationwide
Type
Voluntary: Firm initiated
Recall initiated
January 20, 2023
Terminated
January 16, 2024

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