Drug product
CVS Health Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT 1 OZ (28.4 g) Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895. Made in Canada NDC 59779-305-03
D-0150-2021
Product summary
- Event
- Event 86833
- Status
- Terminated
- Classification
- Class II
- Quantity
- 64,692 1 oz tubes
- Official record key
drug-enforcement:D-0150-2021
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 #: A873430336, Exp Dec-2020
Distribution pattern: Distributed Nationwide in the USA and Canada
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications