Cloderm Cream recalled over manufacturing violations

Recall date

April 23, 2024

Source

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

Official notice title

EPI Health, LLC recalls Cloderm (clocortolone pivalate) Cream, 0.1%, Rx Only, For Topical Use Only, Net Wt 45g, Manufactured for: EPI Health, L…

Recall number

D-0473-2024

FDA classification

Class II

Brand / firm

EPI Health, LLC

Sold / distributed

US Nationwide

Why it was recalled

CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.

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

What was recalled

Cloderm (clocortolone pivalate) Cream, 0.1%, Rx Only, For Topical Use Only, Net Wt 45g, Manufactured for: EPI Health, LLC, Charleston, SC 29403, NDC 71403-804-90