Drug product
RiteAid Pharmacy RIngworm Cream, Clotrimazole Cream USP, 1%, Antifungal NET W 0.5 oz. (14.2g), Distributed by: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011 Made in Canada. UPC 0 11822 53812 1
D-0156-2021
Product summary
- Event
- Event 86833
- Status
- Terminated
- Classification
- Class II
- Quantity
- 34,920 0.5 oz tubes
- Official record key
drug-enforcement:D-0156-2021
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#: A873630559, Exp Dec 2020.
Distribution pattern: Distributed Nationwide in the USA and Canada
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications