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
Recall Number: D-0174-2023
Firm: Lupin Pharmaceuticals Inc.
Classification: Class III
Status: Terminated
Report Date: 20230201
Initiation Date: 20230120
Termination Date: 20240116
Reason for Recall
Subpotent Drug: Low assay result observed during long-term stability testing.
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