D-0341-2022 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
48,816 containers

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.

Distribution Pattern

Nationwide in the USA

Code Information

lot 0LE2178, Exp 1/31/2022; 0ME2516, Exp 4/30/2022