Health Mart, Fexofenadine Hydrochloride tablets, 12HR, 60mg . Antihistamine 12 count bottle, ...
FDA Recall #D-0337-2022 — Class II — July 27, 2021
Product Description
Health Mart, Fexofenadine Hydrochloride tablets, 12HR, 60mg . Antihistamine 12 count bottle, Distributed by: Mckesson 6555 State Highway 161, Irvine, TX 75039. Made in the Czech Republic, NDC 62011-0413-1, UPC 0 52569 14278 3
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
12,384 containers
Distribution
Nationwide in the USA
Code Information
Lot 0JE2491, Exp 1/31/2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated