Drug product
KIRKLAND ALLER-FEX, Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24HR, 180 count bottle, Made in the Czech Republic, Packaged by Perrigo 515 Eastern Ave., Allegan, MI 49010, For Costco Wholesale Corporation. P.O. Box 34535 Seattle, WA 98124-1535, NDC 63981-571-48, UPC 0 96619 98776 4
D-0355-2022
Product summary
- Event
- Event 88384
- Status
- Terminated
- Classification
- Class II
- Quantity
- 42,026 containers
- Official record key
drug-enforcement:D-0355-2022
Official wording
Reason: Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Code information: Lot # 0HV1246, exp 1/1/2022; 0GV1974, 0GV1459, exp 2/1/2022, 0HV1438, exp 3/1/2022, 0KV2116, 0KV2117, exp 5/1/2022; 0KV2119, 0LV2196, 0MV2203, 0MV2204, 0MV2205, exp 6/1/2022;
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out of specification