FDA recall D-0174-2023

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.

Distribution

USA Nationwide

Key facts

Status

Terminated

Initiation date

2023-01-20

Report date

2023-02-01

Termination date

2024-01-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Baltimore, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0174-2023