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
Kroger Jock Itch Cream, Clotrimazole Cream USP, 1%, Antifungal Cream, NET WT .5 OZ (15 g), Distributed by The Kroger CO, Cincinnati, Ohio 45202 Made in Canada, NDC 30142-510-01
Lot numbers, UPCs & expiration codes
Lot#: A873630557, Exp Dec 2020 70,200 63,252
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-0155-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 17, 2020
- FDA report date
- Dec 23, 2020
- Quantity
- 45,396 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
Original FDA data
Every field from FDA enforcement report D-0155-2021, 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#: A873630557, Exp Dec 2020 70,200 63,252
- Postal code
- 10532-2174
- Report date
- Dec 23, 2020
- Product type
- Drugs
- Recall number
- D-0155-2021
- Classification
- Class II
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
- Product quantity
- 45,396 units
- 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
- Kroger Jock Itch Cream, Clotrimazole Cream USP, 1%, Antifungal Cream, NET WT .5 OZ (15 g), Distributed by The Kroger CO, Cincinnati, Ohio 45202 Made in Canada, NDC 30142-510-01
- 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