Drug 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.
D-738-2014
Product summary
- Event
- Event 65181
- Status
- Terminated
- Classification
- Class III
- Quantity
- 104,328/32-caplet packages
- Official record key
drug-enforcement:D-738-2014
Official wording
Reason: Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Code information: Lot # 10116279 exp 05/13 Lot # 10117810 exp 06/13 Lot # 10119274 exp 07/13 Lot # 10121463 exp 07/13
Distribution pattern: Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.
Derived failure modes
-
Unknown
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.