FDA recall D-760-2014

Product

NeoCitran DM Cough & Cold (dextromethorphan hydrobromide 30 mg, phenylephrine hydrochloride 10 mg, pheniramine maleate 20 mg) powder packets, Natural Source Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, UPC 0 58478 05503 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-760-2014