FDA recall D-758-2014

Novartis Consumer Health · Class II · drug

Product

NeoCitran (acetaminophen 1000 mg, pseudoephedrine hydrochloride 60 mg, dextromethorphan hydrobromide 30 mg, chlorpheniramine maleate 4 mg) powder packets, Natural Source Cherry flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, labeled as a) NeoCitran Ultra Strength Total Flu 7 Symptom Relief (UPC 0 58478 47365 9) and b) NeoCitran Extra Strength Sore Throat & Cough (UPC 0 58478 47365 9).

Reason for recall

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

Distribution

Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.

Key facts

Status
Terminated
Initiation date
2013-06-18
Report date
2014-01-29
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-758-2014