FDA-Drug2022-01-12Class II

Perrigo Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 100 count bottle, Made in the Czech Republic, Distributed by Perrigo Allergan, MI 49010 NDC 45802-425-78 UPC 3 45802 425 78 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
41,472 containers
Manufactured in
515 Eastern Ave, N/A, Allegan, MI, United States
Products
Perrigo Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 100 count bottle, Made in the Czech Republic, Distributed by Perrigo Allergan, MI 49010 NDC 45802-425-78 UPC 3 45802 425 78 2

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0346-2022

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