FDA recall D-0336-2022

Perrigo Company PLC · Class II · drug

Product

DG/health Aller.Ease, Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24HR, 10 count bottle, Distributed by: Made in Czech Republic. Distributed by Dolgencorp, LLC, 100 Mission Ridge Goodlettsville, TN 37072. UPC 3 70030 65779 7

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-0336-2022