Rite Aid ALLERGY RELIEF Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, packaged ...

FDA Recall #D-0348-2022 — Class II — July 27, 2021

Recall #D-0348-2022 Date: July 27, 2021 Classification: Class II Status: Terminated

Product Description

Rite Aid ALLERGY RELIEF Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, packaged as a) 30 count bottle, NDC 11822-0571-2 UPC 0 11822 99908 3; b) 150 count bottle, NDC 11822-0571-5 UPC 0 11822 85411 5; Made in the Czech Republic, Distributed by Rite Aid 30 Hunter Lane Camp Hill PA 17011

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

44,688 containers

Distribution

Nationwide in the USA

Code Information

Lot # a) 1BR0462, Exp 10/31/2022 b) 0GR0528, Exp 3/31/2022; 0KR0473, Exp 4/30/2022; 0LR0369, Exp 6/30/2022

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated