EPI Health, LLC: Drug Recall
Recall #D-0473-2024 · 04/23/2024
Class II: Risk
Recall Details
- Recall Number
- D-0473-2024
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- EPI Health, LLC
- Status
- Terminated
- Date Initiated
- 04/23/2024
- Location
- Charleston, SC, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18645 tubes
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.
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
Distribution Pattern
US Nationwide
Other Recalls by EPI Health, LLC
- Class II: Risk 04/23/2024
- Class II: Risk 04/23/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.