Novartis Consumer Health recalls Theraflu Warming Relief, Multi-Symptom Cold, Acetaminophen 325mg, Dextromethorphan HBr 10mg, Phenylephrine HCL 5mg, pack
Recalled January 22, 2014 · FDA recall D-742-2014 · Novartis Consumer Health
Hazard
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing · FDA Class III
Units
98,024/8-caplet packages and 557,548/24-caplet packages
Sold at
Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.
Description
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing
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.
Manufacturer(s)
Novartis Consumer Health
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →