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FEXOFENADINE HYDROCHLORIDE Recall D-0342-2022

Description: 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

FEXOFENADINE HYDROCHLORIDE Recall D-0342-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0342-2022
Event ID88384
BrandFEXOFENADINE HYDROCHLORIDE
Generic NameFEXOFENADINE HCL
ManufacturerFEXOFENADINE HCL
Original Package?1
Active SubstanceFEXOFENADINE HYDROCHLORIDE
Drug RouteORAL
DistributionNationwide in the USA
Quantity65,796 containers
Recall ReasonOut of specification impurity A result obtained during stability testing.
Drug ClassificationClass II
Drug Code Info20220112
Product NDC0904-6979
Drug UPC309046979609
Recall Initiation Date20210727
Report Date20220112
Classification Date20220105
Address515 Eastern Ave
Allegan, MI 49010-9070
United States
Recalling FirmPerrigo Company PLC
Initial Notification Letter
Unique Ingredient Identifier2S068B75ZU
Drug Application NumberANDA076447
Structured Product Labeling (SPL ID)5fdb4f82-4381-4d86-adba-ba4a798ab605
Structured Product Labeling (SPL Set ID)f0ddec5b-27f1-42ec-9276-284d1d2b0181
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