Recalls / Class III
Class IIID-740-2014
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.
- Affected lot / code info
- Lot# 10117243 Exp 06/13 Lot# 10119333 Exp 07/13
Why it was recalled
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Recalling firm
- Firm
- Novartis Consumer Health
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 10401 Hwy 6, Lincoln, Nebraska 68517-9626
Distribution
- Quantity
- 38,856/24-caplet package
- Distribution pattern
- Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.
Timeline
- Recall initiated
- 2013-05-15
- FDA classified
- 2014-01-16
- Posted by FDA
- 2014-01-22
- Terminated
- 2014-11-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-740-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.