Reported Dec 18, 2013 · Terminated

Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/25 mg, Rx only, 7 tablets per bottle, Physician Sample -…

Novartis Pharmaceuticals Corp.

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 Pharmaceuticals Corp. · 25 Old Mill Rd · Suffern, NY · 10901-4106

Is this the product you have?

  • Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/25 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale
  • Manufactured byNovartis Pharma Stein AG Stein, Switzerland
  • Distributed by
    • Novartis Pharmaceuticals Corp. East Hanover
    • New Jersey 07936
    • NDC # 0078-9560-89
Lot codes and dates
  • Product code715515
  • Lot Number
    • F0012
    • Exp 10/31/2013
    • F0013
    • Exp 02/28/2014
    • F0014
    • Exp 03/31/2014
Amount recalled
174,848 bottles

This recall covers 15 products

The agency filed one notice per product. You are reading one of them; the other 14 are below.

2 more are in the archive.

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.

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 Dec 21, 2015 · Data as of Sep 19, 5:49 PM UTC

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