Cloderm recall: CGMP Deviations
Cloderm (clocortolone pivalate) Cream, 0.1%, Rx Only, For Topical Use Only, Net Wt 45g, Manufactured for: EPI Health, LLC, Charleston, SC 29403, NDC…
Why was Cloderm recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
lot SDFC- exp. 5/31/2024 lot TFBW- exp. 5/31/2025
- 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…
- Recalling firm
- EPI Health, LLC
- Quantity
- 18645 tubes
- Distribution
- US Nationwide
- Recall date
- May 1, 2024
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)