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Recall Observatory FDA recall evidence

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

July 27, 2021

Class II

Product summary

Firm
Perrigo Company PLC
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

    reason.potency_specification_failure · v1.0.0

    Out of specification