Wal-Fex Fexofenadine Hydrochloride tablets, 60mg/antihistamine, 12HR, 24 count bottle, Distri...
FDA Recall #D-0353-2022 — Class II — July 27, 2021
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.
Recalling Firm
Perrigo Company PLC — Allegan, MI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
4,536 containers
Distribution
Nationwide in the USA
Code Information
Lot # 0KE2447, 0KE2982, Exp 01/31/2022; 0ME2515, Exp 04/30/2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated