Status
Terminated
Drug Enforcement D-738-2014
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Classification
Class III
Report Date
January 22, 2014
Termination Date
November 4, 2014
Product Information
- Product description
- 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.
- Product quantity
- 104,328/32-caplet packages
- Reason for recall
- Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.
Location & Firm
- Recalling firm
- Novartis Consumer Health
- Address
-
10401 Hwy 6
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-738-2014
- Event ID
- 65181
- Recall initiation date
- May 15, 2013
- Center classification date
- January 16, 2014
- Code info
- Lot # 10116279 exp 05/13 Lot # 10117810 exp 06/13 Lot # 10119274 exp 07/13 Lot # 10121463 exp 07/13
- More code info
- —