EPI Health recalls Cloderm 0.1% topical cream due to quality program discontinuation affecting product safety. No specific remedy provided in recall notice.
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.
EPI Health is recalling Cloderm (clocortolone pivalate) cream because their quality control program was discontinued, which could affect the product's safety. This recall does not include a specific remedy for consumers.
The manufacturer discontinued their quality program, which means the product may not meet safety standards for identity, strength, quality, and purity. This could lead to unsafe effects if the cream does not perform as intended for skin treatment.
People who have the Cloderm 0.1% cream with NDC 71403-804-90, manufactured in Charleston, SC, and sold between 2023-2024 are affected. Those using prescription topical corticosteroids for skin conditions are most at risk.
Check for Cloderm cream labeled 0.1% (Rx Only), 45g net weight, with NDC 71403-804-90. The product was manufactured in Charleston, SC and sold between 2023-2024 with specific expiration dates.
Look for the NDC 71403-804-90 label on the cream's packaging to confirm it is part of this recall.
The recall notice does not provide a remedy for consumers.
The product has two expiration dates: lot SDFC expires 5/31/2024 and lot TFBW expires 5/31/2025.
Check for Cloderm cream with NDC 71403-804-90, manufactured in Charleston, SC, and sold between 2023-2024.
We’ve drafted a message you can send EPI Health to request your refund or repair — edit it as you like.
Subject: Recall D-0473-2024 — EPI Health EPI Health Hello, I own a EPI Health that is covered by recall D-0473-2024 from EPI Health. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
