berkley jensen, ALLERGY RELIEF, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine, 24HR, ...
FDA Recall #D-0333-2022 — Class II — July 27, 2021
Product Description
berkley jensen, ALLERGY RELIEF, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine, 24HR, 150 count bottle, Made in the Czech Republic, Distributed by: BJ's WHolesale Club 25 Research Drive Westborough, MA 01581
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
7,670 containers
Distribution
Nationwide in the USA
Code Information
Lot # 0HV1442, Exp 3/1/2022, 1CV1619, Exp 10/1/2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated