KIRKLAND ALLER-FEX, Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24HR, 180 count bo...
FDA Recall #D-0355-2022 — Class II — July 27, 2021
Product Description
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
Reason for Recall
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Recalling Firm
Perrigo Company PLC — Allegan, MI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
42,026 containers
Distribution
Nationwide in the USA
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;
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated