Clobetasol Propionate Foam recalled over manufacturing violations

Recall date

January 10, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Ingenus Pharmaceuticals Llc recalls 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…

Recall number

D-0374-2022

FDA classification

Class II

Brand / firm

Ingenus Pharmaceuticals Llc

Sold / distributed

Nationwide in the USA

Why it was recalled

CGMP Deviations

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.