FENOFIBRATE- fenofibrate tablet 
MONTELUKAST SODIUM - montelukast sodium tablet, chewable 
Food and Drug Administration

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Warning Letter

https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm588722.htm

FENOFIBRATE 
fenofibrate tablet
Product Information
Product TypeItem Code (Source)NDC:43353-248
Reporting Period20171205-
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FENOFIBRATE (UNII: U202363UOS) (FENOFIBRIC ACID - UNII:BGF9MN2HU1) FENOFIBRATE48 mg
MONTELUKAST SODIUM 
montelukast sodium tablet, chewable
Product Information
Product TypeItem Code (Source)NDC:43353-252
Reporting Period20171205-
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MONTELUKAST SODIUM (UNII: U1O3J18SFL) (MONTELUKAST - UNII:MHM278SD3E) MONTELUKAST5 mg
Labeler - Food and Drug Administration (927645523)

Revised: 12/2017
Document Id: fe5c3dd3-2b26-4afd-b254-2da2f5b6055b
Set id: d78d8e2d-2a80-4666-b1c2-73fc7ee7debf
Version: 1
Effective Time: 20171205
 
Food and Drug Administration