Novartis Consumer Health recalls Maximum Strength Comtrex Nighttime Cold & Cough, Acetaminophen 325mg ,Chlorpheniramine Maleate 2mg, Dextromethorphan HB
Recalled January 22, 2014 · FDA recall D-739-2014 · Novartis Consumer Health
Hazard
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing. · FDA Class III
Units
32,256/24-caplet packages
Sold at
Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.
Description
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Product
Maximum Strength Comtrex Nighttime Cold & Cough, Acetaminophen 325mg ,Chlorpheniramine Maleate 2mg, Dextromethorphan HBR 10mg,Phenylephrine HCL 5mg, packaged in 24 coated caplets nighttime formula *includes antihistamine, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 075054-0622, NDC 0067-2081-24.
Manufacturer(s)
Novartis Consumer Health
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →