Recalls / Class III
Class IIID-742-2014
Product
Theraflu Warming Relief, Multi-Symptom Cold, Acetaminophen 325mg, Dextromethorphan HBr 10mg, Phenylephrine HCL 5mg, packaged in a) 8 coated caplets (NDC 0067-6438-08) 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# 10121228 exp 08/13. b) 24caplets: Lot# 10114814 exp 05/13 Lot# 10117233 exp 05/13 Lot# 10117811 exp 06/13 Lot# 10119338 exp 07/13 Lot# 10121470 exp 07/13 Lot# 10123892 exp 09/13 Lot# 10124161 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
- 98,024/8-caplet packages and 557,548/24-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-742-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.