Skip to content
Recall Observatory FDA recall evidence

Drug 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

D-0473-2024

April 23, 2024

Class II

Product summary

Firm
EPI Health, LLC
Event
Event 94447
Status
Terminated
Classification
Class II
Quantity
18645 tubes
Official record key
drug-enforcement:D-0473-2024

Official wording

Reason: 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.

Code information: lot SDFC- exp. 5/31/2024 lot TFBW- exp. 5/31/2025

Distribution pattern: US Nationwide

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviation