drugs Class III Updated 2014-01-22

Novartis Consumer Health recalls Maximum Strength Comtrex Nighttime Cold & Cough, Acetaminoph

Recalled 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.


Hazard / Issue

Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot # 10119267 exp 07/13 Lot # 10123857 exp 07/13 Lot # 10123888 exp 09/13
View official government recall

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