FDA-Drug2022-01-12Class II

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,

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
14,160 containers
Manufactured in
515 Eastern Ave, N/A, Allegan, MI, United States
Products
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,

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0352-2022

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