FDA recall D-0352-2022

Product

Wal-Fex Fexofenadine Hydrochloride tablets, 180mg/antihistamine, 24HR, packaged as a) 5 count bottle, NDC 0363-0600-13,UPC 3 11917 12267 0, b)30 count bottle, NDC 0363-0600-39 UPC 3 11917 16172 3 c) 90 count bottle, NDC 0363-0600-75 UPC 3 11917 12271 7 ; Distributed by Walgreen Co. 200 Wilmot Rd Deerfield IL 60015, Made in the Czech Republic,

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-0352-2022