Reported Jan 29, 2014 · Terminated

Theraflu MAX-D Severe Cold & Flu (acetaminophen 1000 mg, dextromethorphan HBr 30 mg, guaifenesin 400 mg,…

Novartis Consumer Health

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Novartis Consumer Health · 10401 Hwy 6 · Lincoln, NE · 68517-9626

Is this the product you have?

  • Theraflu MAX-D Severe Cold & Flu (acetaminophen 1000 mg, dextromethorphan HBr 30 mg, guaifenesin 400 mg, pseudoephedrine HCl 60 mg) powder packets, Natural Citrus flavor, 6-count packets per carton
  • Distributed byNovartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-6427-06, UPC 3 0067-6427-06 5
  • Also packaged under foreign labelNeoCitran Extra Strength Total 7 Symptom Relief Plus Mucous Relief powder packets, Soothing Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, UPC 0 58478 10701 1
Lot codes and dates
  • Lot #: 10089568, Exp 5/31/2013; 10093324, 10094745, 10097626, 10097627, Exp 7/31/2013; 10098588, Exp 9/30/2013. NeoCitran Extra Strength Total 7
  • Symptom Relief Plus Mucous Relief
    • 10093316
    • Exp 7/31/2013
    • 10098591
    • Exp 9/30/2013
    • 10101027
    • Exp 10/31/2013
    • 10102623
    • Exp 11/30/2013
    • 10106813
    • Exp 1/31/2014
    • 10115844
    • Exp 6/30/2014
    • 10124363
    • Exp 9/30/2014
Amount recalled
868,104 cartons

This recall covers 16 products

The agency filed one notice per product. You are reading one of them; the other 15 are below.

3 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Nov 4, 2014 · Data as of Sep 19, 5:49 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.