drugs Class II Updated 2014-01-29

Novartis Consumer Health recalls Theraflu Flu & Sore Throat (acetaminophen 650 mg, pheniramin

Recalled Product

Theraflu Flu & Sore Throat (acetaminophen 650 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Natural Apple Cinnamon flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-7916-06, UPC 3 0043-0479-16 3. Also packaged under foreign label: NeoCitran Extra Strength Cold & Flu (acetaminophen 650 mg, phenylephrine hydrochloride 10 mg, pheniramine maleate 20 mg) powder packets, Apple Cinnamon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, UPC 0 58478 05205 2.

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 #: 10115121, 10115832, Exp 5/31/2013; 10119854, 10119856, Exp 7/31/2013; 10122257, 8/31/2013; 10124286, 10124289, 10124292, Exp 9/30/2013; 10128103, 10128105, 10128108, 10128110, Exp 10/31/2013. NeoCitran Cold & Flu: 10115118, Exp 5/31/2013 and 10122252, Exp 9/30/2013.
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