PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: May 1, 2024 Initiated: April 23, 2024 #D-0473-2024

Product Description

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.

Details

Recalling Firm
EPI Health, LLC
Units Affected
18645 tubes
Distribution
US Nationwide
Location
Charleston, SC

Frequently Asked Questions

What product 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. Recalled by EPI Health, LLC. Units affected: 18645 tubes.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 1, 2024. Severity: Moderate. Recall number: D-0473-2024.