FDA recall D-0329-2022

Perrigo Company PLC · Class II · drug

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.

Reason for recall

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

Distribution

Nationwide in the USA

Key facts

Status: Terminated
Initiation date: 2021-07-27
Report date: 2022-01-12
Termination date: 2022-11-08
Voluntary/Mandated: Voluntary: Firm initiated
Location: Allegan, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0329-2022