D-0473-2024 Class II Terminated
FDA drug recall D-0473-2024 was initiated by EPI Health, LLC on Apr 23, 2024 and is designated Class II. 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… The recall status is terminated (terminated Sep 12, 2024). Affected quantity: 18645 tubes.
Recall details
- Product Type
- Drugs
- Report Date
- May 1, 2024
- Initiation Date
- Apr 23, 2024
- Termination Date
- Sep 12, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18645 tubes
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.
Distribution pattern
US Nationwide
Code information
lot SDFC- exp. 5/31/2024 lot TFBW- exp. 5/31/2025
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0473-2024
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026