Drug product
Kroger Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT 0.5 OZ (15g), Distributed by The Kroger Co. Cincinnati, Ohio 45202 Made in Canada. NDC 30142-305-01
D-0154-2021
Product summary
- Event
- Event 86833
- Status
- Terminated
- Classification
- Class II
- Quantity
- 133,452 0.5 oz tubes
- Official record key
drug-enforcement:D-0154-2021
Official wording
Reason: Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Code information: Lot#: A873430372, Exp Dec 2020; D867331278, Exp Mar 2021
Distribution pattern: Distributed Nationwide in the USA and Canada
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications