Why it was 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.
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
Lot numbers, UPCs & expiration codes
lot SDFC- exp. 5/31/2024 lot TFBW- exp. 5/31/2025
Where it was sold
US Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0473-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 23, 2024
- FDA report date
- May 1, 2024
- Quantity
- 18645 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- EPI Health, LLC
Original FDA data
Every field from FDA enforcement report D-0473-2024, exactly as published.
Show all FDA fields
- City
- Charleston
- State
- SC
- Status
- Terminated
- Country
- United States
- Event ID
- 94447
- Address
- 174 Meeting St Ste 200
- Code information
- lot SDFC- exp. 5/31/2024 lot TFBW- exp. 5/31/2025
- Postal code
- 29401-3211
- Report date
- May 1, 2024
- Product type
- Drugs
- Recall number
- D-0473-2024
- Classification
- Class II
- Recalling firm
- EPI Health, LLC
- Product quantity
- 18645 tubes
- Termination date
- Sep 12, 2024
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Recall initiation date
- Apr 23, 2024
- Initial firm notification
- Letter
- Center classification date
- Apr 25, 2024