Novartis Consumer Health recalls Theraflu (acetaminophen 325 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Natural Le
Recalled January 29, 2014 · FDA recall D-751-2014 · Novartis Consumer Health
Hazard
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances. · FDA Class II
Units
1,140,564 cartons
Sold at
Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.
Description
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
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
Manufacturer(s)
Novartis Consumer Health
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →