Kroger Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 12 count bot...
FDA Recall #D-0341-2022 — Class II — July 27, 2021
Product Description
Kroger Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 12 count bottle, Distributed by the Kroger CO. Cincinnati, Ohio 45202. Made in the Czech Republic, NDC 30142-555-53 UPC 0 41260 35588 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
48,816 containers
Distribution
Nationwide in the USA
Code Information
lot 0LE2178, Exp 1/31/2022; 0ME2516, Exp 4/30/2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated