amazon basic+care, Allergy Fexofenadine Hydrochloride Tablets, 60 mg/Antihistamine, 12HR, 100 co...

FDA Recall #D-0354-2022 — Class II — July 27, 2021

Recall #D-0354-2022 Date: July 27, 2021 Classification: Class II Status: Terminated

Product Description

amazon basic+care, Allergy Fexofenadine Hydrochloride Tablets, 60 mg/Antihistamine, 12HR, 100 count bottle, Made in the Czech Republic, Distributed by: Amazon.com services LLC 410 Terry Avenue N., Seattle WA 98109, NDC 72288-425-78 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

38,352 bottles

Distribution

Nationwide in the USA

Code Information

Lot # 1AR0558, Exp 7/31/2022

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated