Novartis Consumer Health recalls Maximum Strength Comtrex ,Severe Cold & Sinus Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Phenylephrine HCL 5mg
Recalled January 22, 2014 · FDA recall D-741-2014 · Novartis Consumer Health
Hazard
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing. · FDA Class III
Units
167,712/24-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 ,Severe Cold & Sinus Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Phenylephrine HCL 5mg, packaged in 12 coated caplets daytime formula and 12 coated caplets nighttime formula. Novartis, distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622, NDC 0067-2081-24
Manufacturer(s)
Novartis Consumer Health
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →