Cloderm (clocortolone pivalate) Cream, 0.1%, Rx Only, For Topical Use Only, Net Wt 45g, Manufactured for: EPI Health, LL
Summary
The FDA issued a Class II for Cloderm (clocortolone pivalate) Cream, 0.1%, Rx Only, For Topical Use Only, Net by EPI Health, LLC. Reason: CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity char.
Details
Source
Drug Recall
External ID
D-0473-2024
Action Date
2024-05-01
Status
Terminated
Category
drug
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/Code Info: lot SDFC- exp. 5/31/2024 lot TFBW- exp. 5/31/2025
Quantity Affected: 18645 tubes
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
US Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-23
Company
Charleston, SC
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 96 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
EPI Health, LLC has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (EPI Health, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does EPI Health, LLC have FDA actions?
EPI Health, LLC has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0473-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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