FDA recall D-0356-2022

Perrigo Company PLC · Class II · drug

Product

CVS Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine, 24HR, 30 count bottle, NDC 69842-698-39, UPC 0 50428 62564 4

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-0356-2022