FDAClass IIJanuary 12, 2022

GoodSense Aller.Ease recall: Impurity Out of Spec

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.

Why was GoodSense Aller.Ease recalled?

Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
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.
Recalling firm
Perrigo Company PLC
Quantity
36,048 containers
Distribution
Nationwide in the USA
Recall date
January 12, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls