Drug 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.
D-739-2014
Product summary
- Event
- Event 65181
- Status
- Terminated
- Classification
- Class III
- Quantity
- 32,256/24-caplet packages
- Official record key
drug-enforcement:D-739-2014
Official wording
Reason: Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Code information: Lot # 10119267 exp 07/13 Lot # 10123857 exp 07/13 Lot # 10123888 exp 09/13
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.