Drug product
H-E-B - Athlete's Foot Cream Clotrimazole Cream USP, 1% Anitfungal NET WT. 0.5 oz. (14.2 g), Made with Pride & Care for H-E-B San Antonio, TX 78204 Made in Canada NDC 37808-305-01
D-0152-2021
Product summary
- Event
- Event 86833
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0152-2021
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#: A873630558 Dec-2020; D867331276, Exp Mar-2021
Distribution pattern: Distributed Nationwide in the USA and Canada
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications