FDA recall D-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.

Reason for recall

Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.

Distribution

Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.

Key facts

Status

Terminated

Initiation date

2013-05-15

Report date

2014-01-22

Termination date

2014-11-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lincoln, NE, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-743-2014