Class III
Terminated
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.
- Company
- Novartis Consumer Health
- Recall Initiated
- May 15, 2013
- Posted
- January 22, 2014
- Recall Number
- D-738-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 104,328/32-caplet packages
- Firm Location
- Lincoln, NE, United States
Reason for Recall
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Distribution
Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.
Lot / Code Info
Lot # 10116279 exp 05/13 Lot # 10117810 exp 06/13 Lot # 10119274 exp 07/13 Lot # 10121463 exp 07/13
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