D-0329-2022 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
36,048 containers

Product Description

GoodSense Aller.Ease, Fexofenadine hydrochloride 12 HR, 60 mg tablets, 24 count bottle, UPC 3 0113 0425 62 7; Made in the Czech Republic, Distributed by: Perrigo Allergan MI 49010.

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# 0JE2487 , 0KE2982, Exp 1/31/2022