Reported Jan 29, 2014 · Terminated

Theraflu Flu & Sore Throat (acetaminophen 650 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10 mg) powder…

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 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 byNovartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-7916-06, UPC 3 0043-0479-16 3
  • Also packaged under foreign labelNeoCitran 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
Lot codes and dates
    • 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
Amount recalled
1,614,564 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, 5:01 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.