Clotrimazole Cream
FDA Recall NDC 49035-812
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Clotrimazole (NDC 49035-812). A significant event, classified as Class II, was initiated on Nov 17, 2020 by Wal-mart Stores, Inc.. The reported reason for this action was: "Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
November 2020 Class II Recall: Failed Impurities/Degradation Specifications
Recall Number
Class II Terminated
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Nov 17, 2020
Dec 23, 2020
481,896 tubes
Recall Profile & Regulatory Data
Event ID
86833
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Taro Pharmaceuticals U.S.A., Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA and Canada
Termination Date
Feb 21, 2024
Product Description
Equate Athlete's Foot, Clotrimazole USP 1%, Antifungal Cream, Packaged as a) NET WT. 0.5 oz (14.2g), NDC 49035-812-01, b) NET WT 2 OZ (60g), NDC 49035-812-27. Distributed by: Walmart Inc., Bentonville, AR 72716.
Batch or Lot Expiration Information
Lot# : a)A873430371, Exp Dec-2020; B870030918, Exp Jan-2021; C868330918, Exp Feb-2021 b) A873430406, A873530406, A873630406, Exp Dec-2020;B870030635, B870130867, Exp Jan-2021; C868330867, Exp Feb-2021
Affected Packages Involved in this Recall
49035-812-01Product
49035-812-27Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
