The Recall Desk
HighFDA (Drugs)·D-0473-2024·Announced 2024-05-01

Cloderm Cream Recalled for Manufacturer Quality Assurance Program Discontinuation

EPI Health is recalling Cloderm cream due to discontinuation of the manufacturer's quality assurance program. This may result in products that do not meet specifications for identity, strength, purity, or quality.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall. The hazard is a manufacturing quality control deviation where the manufacturer's quality assurance program was discontinued. This creates theoretical risk that products may not meet specifications for identity, strength, purity, or quality. No illnesses or injuries are mentioned in the recall notice. Per the rubric, this is a risk-of-harm product where injury has not yet been reported, scoring as High.

Plain-English summary

Cloderm (clocortolone pivalate) Cream 0.1%, a topical corticosteroid medication, manufactured by EPI Health, LLC in Charleston, South Carolina, is being recalled. The product is available by prescription only in 45-gram tubes.

The recall was initiated due to a deviation from Current Good Manufacturing Practice (CGMP). The manufacturer discontinued its quality assurance program, which was designed to ensure that products meet specifications for identity, strength, purity, and quality. Without this program, products in circulation may not possess the characteristics they are represented to have.

The affected lot numbers are SDFC- (expiration date 5/31/2024) and TFBW- (expiration date 5/31/2025). Approximately 18,645 tubes were distributed nationwide. Patients who have this medication should consult their healthcare provider about continued use.

The recalled product

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
Manufacturer
EPI Health, LLC
Category
Drug — Topical / Corticosteroid
Hazard
  • cgmp-deviation
  • quality-control-failure
  • potency-deviation
  • impurity-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • lot SDFC- exp. 5/31/2024 lot TFBW- exp. 5/31/2025

Distribution

Distributed nationwide across the United States.

Related recalls

Same category