FDA recall D-0473-2024

Product

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

Reason for recall

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.

Distribution

US Nationwide

Key facts

Status

Terminated

Initiation date

2024-04-23

Report date

2024-05-01

Termination date

2024-09-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Charleston, SC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0473-2024