Novartis Consumer Health recalls Theraflu Nighttime Warming Relief Nighttime Multi-Symptom Cold, Acetaminophen 325mg , Chlorpheniramine Maleate 2mg , Dex
Recalled January 22, 2014 · FDA recall D-743-2014 · Novartis Consumer Health
Hazard
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing. · FDA Class III
Units
3,768/8-caplet packages and 300,580/24-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 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.
Manufacturer(s)
Novartis Consumer Health
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →