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
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
CGMP Deviation