Status
Terminated
Drug Enforcement D-740-2014
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 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.
- Product quantity
- 38,856/24-caplet package
- 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-740-2014
- Event ID
- 65181
- Recall initiation date
- May 15, 2013
- Center classification date
- January 16, 2014
- Code info
- Lot# 10117243 Exp 06/13 Lot# 10119333 Exp 07/13
- More code info
- —