Drug 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
D-0153-2021
Product summary
- Event
- Event 86833
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30,816 1 oz tubes
- Official record key
drug-enforcement:D-0153-2021
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#: A873630634, Exp Dec 2020; B870030634, Exp, Jan 2021
Distribution pattern: Distributed Nationwide in the USA and Canada
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications