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

Recall Number: D-0342-2022

Firm: Perrigo Company PLC

Classification: Class II

Status: Terminated

Report Date: 20220112

Initiation Date: 20210727

Termination Date: 20221108

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

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