basic+care, allergy Fexofenadine Hydrochloride Tablets, 60 mg/Antihistamine, 12HR, 100 count bot...
FDA Recall #D-0332-2022 — Class II — July 27, 2021
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.
Recalling Firm
Perrigo Company PLC — Allegan, MI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
62,568 containers
Distribution
Nationwide in the USA
Code Information
Lot # 0CR0510, Exp 9/30/2021; 0LR0361, Exp 04/30/2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated