D-0332-2022 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
62,568 containers

Product Description

basic+care, allergy Fexofenadine Hydrochloride Tablets, 60 mg/Antihistamine, 12HR, 100 count bottle, Made in the Czech Republic, Distributed by: Perrigo Allergan, MI 49010, NDC 0113-7425-78 UPC 3 70030 14536 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 # 0CR0510, Exp 9/30/2021; 0LR0361, Exp 04/30/2022