FDA recall D-751-2014

Product

Theraflu (acetaminophen 325 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Natural Lemon flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, labeled as a) Theraflu Sinus & Cold (NDC 0067-6319-06, UPC 3 0043-6319-06 7) and b) Theraflu Cold & Sore Throat (NDC 0067-6716-06, UPC 3 0043-0467-16 0). Also packaged under foreign labels: NeoCitran Cold & Flu powder packets, Natural Source Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, UPC 0 58478 05009 6; and Theraflu Exthegran powder packets, lemon flavor, packaged in a) 6-count packets per carton (UPC 7 501124 812904) and b) 10-count packets per carton (UPC 7 501124 814588), Distributed by Novartis Farmaceutica S.A. De C.V., Mexico

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-751-2014