The Recall Desk
HighFDA (Drugs)·D-1374-2022·Announced 2022-08-31

Antifungal Cream Recalled for Improper Storage Temperature Conditions

Family Dollar's FS Clotrimazole Anti Fungal Cream is being recalled due to improper storage temperature conditions. The product was distributed nationwide between April 30 and June 10, 2022.

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: This is an FDA Class II recall of a medication (risk-of-harm product) due to CGMP deviations involving improper storage conditions. While no illnesses or injuries have been reported, the identified storage deviation could affect product quality, warranting a High severity classification.

Plain-English summary

Family Dollar Stores, LLC is recalling FS Clotrimazole Anti Fungal Cream 0.5 oz due to Current Good Manufacturing Practice (CGMP) deviations. The product was held outside appropriate storage temperature conditions, which may have compromised product quality.

The recalled product was distributed nationwide to specific Family Dollar stores between April 30, 2022 and June 10, 2022 (SKU: 910334).

Consumers who have purchased this product should discontinue use and discard it. Anyone with questions or concerns should consult their healthcare provider.

The recalled product

Product
FS CLOTRIMAZOLE ANTI FUNGAL CREAM .5 OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Manufacturer
Family Dollar Stores, Llc.
Category
Drug — Topical Antifungal
Hazard
  • improper-storage
  • potential-contamination

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)

  • SKU: 910334

Distribution

Distributed nationwide across the United States.

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