Cloderm — Class II drug recall D-0473-2024
Terminated recall by EPI Health, LLC, reported 2024-05-01, distributed nationwide. CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the iden
| Recall number | D-0473-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | EPI Health, LLC, Charleston, SC, United States |
| Recall initiated | 2024-04-23 |
| Classified | 2024-04-25 |
| Reported by FDA | 2024-05-01 |
| Terminated | 2024-09-12 |
| Distributed | Nationwide (US) |
| Quantity | 18,645 tubes |
| Reason classes | potency, cgmp |
| NDC | 71403-0804-90 |
| Expiration dates | 2024-05-31, 2025-05-31 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0473-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.