FDA recall D-0374-2022

Product

Clobetasol Propionate Foam, 0.05%, packaged in a) 50 g can (NDC 50742-304-50), and b) 100 g can (NDC 50742-304-01), Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL 32839-6408.

Reason for recall

CGMP Deviations

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2022-01-10

Report date

2022-01-26

Termination date

2023-08-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Orlando, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0374-2022