The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0156-2021·Announced 2020-12-23

Taro Recalls Rite Aid Clotrimazole Cream Due to Impurity

Taro Pharmaceuticals is recalling Rite Aid Clotrimazole Cream because an unknown degradation impurity was detected slightly above the specification limit.

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, and the source text describes the impurity as 'slightly above the specification limit' without reporting any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Taro Pharmaceuticals U.S.A., Inc. is recalling Rite Aid Pharmacy Ringworm Cream, Clotrimazole Cream USP, 1%, Antifungal. The recall involves 34,920 0.5 oz tubes of the product, which was distributed nationwide in the USA and Canada. The specific lot number is A873630559, with an expiration date of December 2020.

The recall was initiated because an unknown degradation impurity was detected in the product at a level slightly above the specification limit. This is a Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers who have purchased this specific lot of Rite Aid Pharmacy Ringworm Cream should stop using it and return it to the place of purchase for a refund or contact Taro Pharmaceuticals for further instructions.

The recalled product

Product
RiteAid Pharmacy RIngworm Cream, Clotrimazole Cream USP, 1%, Antifungal NET W 0.5 oz. (14.2g), Distributed by: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011 Made in Canada. UPC 0 11822 53812 1
Manufacturer
Taro Pharmaceuticals U.S.A., Inc.
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#: A873630559
  • Exp Dec 2020.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 10 recalled by Taro Pharmaceuticals U.S.A., Inc. 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 10 products in this recall →

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