drugs Class III Updated 2014-01-22

Novartis Consumer Health recalls Maximum Strength Comtrex Day/Night Cold & Cough, Acetaminoph

Recalled Product

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.

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot # 10116279 exp 05/13 Lot # 10117810 exp 06/13 Lot # 10119274 exp 07/13 Lot # 10121463 exp 07/13
View official government recall

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