The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1043-2016·Announced 2016-06-29

Profarma Recalls 1% Clotrimazole Cream Due to Manufacturing Deviations

Profarma Distributors LLC is recalling 79 tubes of 1% Clotrimazole cream due to CGMP deviations. The recall is voluntary and nationwide.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II due to CGMP deviations, which typically indicates a remote probability of serious adverse health consequences or temporary/reversible effects, aligning with the Moderate severity criteria for low-risk contamination or voluntary precautionary recalls.

Plain-English summary

Profarma Distributors LLC is voluntarily recalling 79 boxes (79 tubes) of 1% Clotrimazole cream, 30 mg tube, UPC 501318644335. The affected product is identified by Lot # GRU1390 and an expiration date of 08/17. The recall was initiated on May 11, 2016, and was distributed nationwide.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The FDA classified this recall as Class II, which indicates a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Consumers who have this product should stop using it and contact Profarma Distributors LLC for further instructions or a refund. The recall was terminated on January 24, 2017.

The recalled product

Product
1% Clotrimazol cream, 30 mg tube, UPC 501318644335
Manufacturer
Profarma Distributors LLC
Category
Drug — Topical Antifungal
Hazard

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 (2)

  • Lot # GRU1390
  • Exp. 08/17

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by Profarma Distributors LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

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