PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: January 12, 2022 Initiated: July 27, 2021 #D-0329-2022

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.

Details

Recalling Firm
Perrigo Company PLC
Units Affected
36,048 containers
Distribution
Nationwide in the USA
Location
Allegan, MI

Frequently Asked Questions

What product was recalled?
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.. Recalled by Perrigo Company PLC. Units affected: 36,048 containers.
Why was this product recalled?
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Which agency issued this recall?
This recall was issued by the FDA Drug on January 12, 2022. Severity: Moderate. Recall number: D-0329-2022.