Drug product
Maximum Strength Comtrex , Day/Night Flu Therapy , Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Dextromethorphan HBr 10mg, Phenylephrine HCL 5mg, packaged in 12 coated caplets daytime formula and 12 coated caplets nighttime formula. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622, NDC 0067-2084-24.
D-740-2014
Product summary
- Event
- Event 65181
- Status
- Terminated
- Classification
- Class III
- Quantity
- 38,856/24-caplet package
- Official record key
drug-enforcement:D-740-2014
Official wording
Reason: Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Code information: Lot# 10117243 Exp 06/13 Lot# 10119333 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.