D-0353-2022 Class II Terminated

Recalled by Perrigo Company PLC — Allegan, MI

Recall Details

Product Type
Drugs
Report Date
January 12, 2022
Initiation Date
July 27, 2021
Termination Date
November 8, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4,536 containers

Product Description

Wal-Fex Fexofenadine Hydrochloride tablets, 60mg/antihistamine, 12HR, 24 count bottle, Distributed by Walgreen Co. 200 Wilmot Rd Deerfield IL 60015, Made in the Czech Republic, NDC 0363-0903-62 UPC 3 11917 18625 2

Reason for Recall

Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.

Distribution Pattern

Nationwide in the USA

Code Information

Lot # 0KE2447, 0KE2982, Exp 01/31/2022; 0ME2515, Exp 04/30/2022