basic+care, allergy Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24 HR, 150 count b...
FDA Recall #D-0331-2022 — Class II — July 27, 2021
Product Description
basic+care, allergy Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24 HR, 150 count bottle, Made in the Czech Republic, Distributed by: Perrigo Allergan, MI 49010, NDC 0113-7571-47 UPC 3 70030 11470 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
28,320 containers
Distribution
Nationwide in the USA
Code Information
Lot # 0GR0528, Exp 03/31/22; 0KR0473, Exp 04/30/22; 0LR0369, Exp 06/30/22
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated