Reported Jan 29, 2014 · Terminated

Theraflu Cold and Flu (acetaminophen 325 mg, phenylephrine hydrochloride 10 mg and pheniramine maleate 20 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 Cold and Flu (acetaminophen 325 mg, phenylephrine hydrochloride 10 mg and pheniramine maleate 20 mg) powder packets, Forest Berries flavor, 10-count packets per box, UPC 4 607045 191760. (Russian product and Former Soviet Union product)
Lot codes and dates
  • Lot #:
  • Russia product
    • 10117513
    • 10117515
    • 10117517
    • 10117520
    • 10118676
    • 10118680
    • Exp 6/30/2013
  • and Former Soviet Union product
    • 10116986
    • 10116988
    • Exp 8/31/2013

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, 6:32 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.