Why it was recalled
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
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.
Lot numbers, UPCs & expiration codes
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
Where it was sold
Distributed Nationwide in the USA and Canada
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0151-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 17, 2020
- FDA report date
- Dec 23, 2020
- Quantity
- 481,896 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
Original FDA data
Every field from FDA enforcement report D-0151-2021, exactly as published.
Show all FDA fields
- City
- Hawthorne
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 86833
- Address
- 3 Skyline Dr
- Code 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
- Postal code
- 10532-2174
- Report date
- Dec 23, 2020
- Product type
- Drugs
- Recall number
- D-0151-2021
- Classification
- Class II
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
- Product quantity
- 481,896 tubes
- Termination date
- Feb 21, 2024
- Reason for recall
- Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Distributed Nationwide in the USA and Canada
- Recall initiation date
- Nov 17, 2020
- Initial firm notification
- Letter
- Center classification date
- Dec 16, 2020