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GoodSense Aller.Ease, Fexofenadine hydrochloride 12 HR, 60 mg tablets, 24 count bottle, UPC 3 011...

FDA Recall #D-0329-2022 — Class II — July 27, 2021

Recall #D-0329-2022 Date: July 27, 2021 Classification: Class II Status: Terminated

Product Description

GoodSense Aller.Ease, Fexofenadine hydrochloride 12 HR, 60 mg tablets, 24 count bottle, UPC 3 0113 0425 62 7; Made in the Czech Republic, Distributed by: Perrigo Allergan MI 49010.

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

36,048 containers

Distribution

Nationwide in the USA

Code Information

Lot# 0JE2487 , 0KE2982, Exp 1/31/2022

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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