The Recall Desk
ModerateFDA (Drugs)·D-0153-2021·Announced 2020-12-23

Taro Recalls Kaiser Permanente Clotrimazole Cream Due to Impurity

Taro Pharmaceuticals is recalling specific lots of Kaiser Permanente Clotrimazole Cream USP 1% because an unknown degradation impurity was detected slightly above the specification limit.

What this means for you

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, which typically corresponds to a moderate severity score (2) when no specific hospitalizations or serious injuries are reported in the source text, and the deviation is described as 'slightly above' the limit.

Plain-English summary

Taro Pharmaceuticals U.S.A., Inc. is recalling 30,816 tubes of Kaiser Permanente Clotrimazole Cream USP, 1% Antifungal Cream. The product is a 1 oz (28.4 g) tube manufactured in Canada and distributed by Kaiser Foundation Hospitals in Livermore, CA. The recall covers two specific lots: A873630634 (Expiration: Dec 2020) and B870030634 (Expiration: Jan 2021).

The recall was initiated because an unknown degradation impurity was detected in the cream at levels slightly above the established specification limit. This is a Class II recall, indicating a situation that might cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The affected product was distributed nationwide in the USA and Canada. Consumers should check their medication for the specific lot numbers and expiration dates listed above. If they have the affected product, they should stop using it and contact their healthcare provider or pharmacist for guidance on disposal or replacement.

The recalled product

Product
Kaiser Permanente Clotrimazole Cream USP, 1% Antifungal Cream, NET WT 1 oz (28.4 g), Manufactured by Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T1C1 Distributed by Kaiser Foundation Hospitals Livemore, CA 94551-9756. Made in Canada. NDC 0179-8014-30
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 (5)

  • Lot#: A873630634
  • Exp Dec 2020
  • B870030634
  • Exp
  • Jan 2021

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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