Drug product
Kroger Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 12 count bottle, Distributed by the Kroger CO. Cincinnati, Ohio 45202. Made in the Czech Republic, NDC 30142-555-53 UPC 0 41260 35588 2
D-0341-2022
Product summary
- Event
- Event 88384
- Status
- Terminated
- Classification
- Class II
- Quantity
- 48,816 containers
- Official record key
drug-enforcement:D-0341-2022
Official wording
Reason: Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Code information: lot 0LE2178, Exp 1/31/2022; 0ME2516, Exp 4/30/2022
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out of specification