H.E.B Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg/Antihistamine 12 count b...
FDA Recall #D-0339-2022 — Class II — July 27, 2021
Product Description
H.E.B Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg/Antihistamine 12 count bottle, Made with Pride & Care for H.E.B. San Antonio TX 78204, Product of Czech Republic, NDC 37808-425-53, UPC 0 41220 53080 9
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
26,304 containers
Distribution
Nationwide in the USA
Code Information
Lot 0JE2491, 0LE2178, Exp 01/31/2022; 0ME2516, Exp 4/30/2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated