drugs Class II Updated 2014-01-29

Novartis Consumer Health recalls Theraflu (acetaminophen 325 mg, pheniramine maleate 20 mg, p

Recalled 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

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot #: a) 10116014, Exp 6/30/2013; 10122246, Exp 7/31/2013; 10124322, Exp 9/30/2013; 10128122, Exp 11/30/2013; b) 10119852, Exp 7/31/2013; 10122249, Exp 8/31/2013; 10124321, Exp 9/30/2013; 10128118, Exp 11/30/2013; 10128120, Exp 11/30/2013. NeoCitran Cold & Flu: 10115576, Exp 6/30/2013; 10122243, Exp 8/31/2013 and 10124319, Exp 9/30/2013; Theraflu Exthegran 10115579, 10115572, Exp 6/30/2013; 10117549, Exp 8/30/2013.
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