Recalls / Class III
Class IIID-743-2014
Product
Theraflu Nighttime Warming Relief Nighttime Multi-Symptom Cold, Acetaminophen 325mg , Chlorpheniramine Maleate 2mg , Dextromethorphan HBr 10mg , Phenylephrine HCL 5mg, a) 8 coated caplets (NDC 0067-6437-08) b) 24 coated caplets (NDC 0067-6438-24). Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622.
- Affected lot / code info
- a) 08 caplets: Lot# 10121222 exp 07/13. b) 24 caplets: Lot# 10117231 exp 06/13 Lot# 10117814 exp 06/13 Lot# 10119341 exp 07/13 Lot# 10123425 exp 08/13 Lot# 10124156 exp 10/13
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
- 3,768/8-caplet packages and 300,580/24-caplet packages
- 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-743-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.