FDA-Drug2022-01-12Class II
MAJOR, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 100 count bottle, Distributed by Major Pharmaceuticals 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152. Made in the Czech Republic, NDC 0904-6979-60 UPC 3 09046 97960 9
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
65,796 containers
Manufactured in
515 Eastern Ave, N/A, Allegan, MI, United States
Products
MAJOR, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 100 count bottle, Distributed by Major Pharmaceuticals 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152. Made in the Czech Republic, NDC 0904-6979-60 UPC 3 09046 97960 9
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0342-2022Don't want to check this manually?
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