FDA-Drug2024-05-01Class II

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

EPI Health, LLC
Hazard

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.

Sold states
US Nationwide
Affected count
18645 tubes
Manufactured in
174 Meeting St Ste 200, N/A, Charleston, SC, United States
Products
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

Official notice

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

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