Class IITerminated

Cloderm (clocortolone pivalate) Cream recall

FDA recall D-0473-2024 · initiated Apr 23, 2024

May cause temporary or medically reversible harm; low probability of serious harm.

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.

Details

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 71403-804-90
Recalling company: EPI Health, LLC
Classification: Class II
Status: Terminated
Type: Voluntary: Firm initiated
Distribution: US Nationwide
Initiated: Apr 23, 2024
FDA report date: May 1, 2024

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0473-2024 ↗

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