Drug Enforcement D-0174-2023

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

Status

Terminated

Classification

Class III

Report Date

February 1, 2023

Termination Date

January 16, 2024

Product Information

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
Product quantity
5720 tubes
Reason for recall
Subpotent Drug: Low assay result observed during long-term stability testing.
Recall initiation reason
—
Initial firm notification
E-Mail
Distribution pattern
USA Nationwide

Location & Firm

Recalling firm
Lupin Pharmaceuticals Inc.
Address
Harborplace Tower, 111 S Calvert St Fl 21st

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0174-2023
Event ID
91532
Recall initiation date
January 20, 2023
Center classification date
January 23, 2023
Code info
Lot#: K101033; Exp 6/2024
More code info
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