FDA-Drug2022-01-12Class II

Wal-Fex Fexofenadine Hydrochloride tablets, 60mg/antihistamine, 12HR, 24 count bottle, Distributed by Walgreen Co. 200 Wilmot Rd Deerfield IL 60015, Made in the Czech Republic, NDC 0363-0903-62 UPC 3 11917 18625 2

Perrigo Company PLC
Hazard

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

Sold states
Nationwide in the USA
Affected count
4,536 containers
Manufactured in
515 Eastern Ave, N/A, Allegan, MI, United States
Products
Wal-Fex Fexofenadine Hydrochloride tablets, 60mg/antihistamine, 12HR, 24 count bottle, Distributed by Walgreen Co. 200 Wilmot Rd Deerfield IL 60015, Made in the Czech Republic, NDC 0363-0903-62 UPC 3 11917 18625 2

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0353-2022

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