Class II Recall

Perrigo Company PLC

Product
Wal-Fex Fexofenadine Hydrochloride tablets, 180mg/antihistamine, 24HR, packaged as a) 5 count bottle, NDC 0363-0600-13,UPC 3 11917 12267 0, b)30 count bottle, NDC 0363-0600-39 UPC 3 11917 16172 3 c) 90 count bottle, NDC 0363-0600-75 UPC 3 11917 12271 7 ; Distributed by Walgreen Co. 200 Wilmot Rd Deerfield IL 60015, Made in the Czech Republic,
Reason
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Classification
Class II
Status
Terminated
Lot
Lot # a)0JE2406, Exp 02/28/2022 b) 0FR0459, Exp 02/28/2022. c) 0KR0465, Exp 04/30/2022
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.