D-0473-2024 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 1, 2024
- Initiation Date
- April 23, 2024
- Termination Date
- September 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