Clobetasol propionate Cream USP, 0.05%, 45 g tube, Rx only, Manufactured for: Lupin Pharmaceutica...
FDA Recall #D-0174-2023 — Class III — January 20, 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.
Recalling Firm
Lupin Pharmaceuticals Inc. — Baltimore, MD
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
5720 tubes
Distribution
USA Nationwide
Code Information
Lot#: K101033; Exp 6/2024
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated