FDA-Drug2014-01-22Class III
Maximum Strength Comtrex Day/Night Cold & Cough, Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Dextromethorphan HBR 10mg, Phenylephrine HCL 5mg, packaged in 16 coated caplets daytime formula and 16 coated caplets nighttime formula *includes antihistamine Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 075054-0622, NDC 0067-2082-32.
Novartis Consumer Health
Hazard
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Sold states
Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.
Affected count
104,328/32-caplet packages
Manufactured in
10401 Hwy 6, Lincoln, NE, United States
Products
Maximum Strength Comtrex Day/Night Cold & Cough, Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Dextromethorphan HBR 10mg, Phenylephrine HCL 5mg, packaged in 16 coated caplets daytime formula and 16 coated caplets nighttime formula *includes antihistamine Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 075054-0622, NDC 0067-2082-32.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-738-2014Don't want to check this manually?
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