Reported Dec 18, 2013 · Terminated

Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets 300/25 mg, 7 tablets per bottle, Physician Sample-Not For…

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?

  • Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets 300/25 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only
  • Manufactured byNovartis Pharma Productions GmbH Wehr, Germany
  • Distributed by
    • Novartis Pharmaceuticals Corp. East Hanover
    • New Jersey 07936
    • NDC # 0078-9524-89
Lot codes and dates
  • Product code712427
  • Lot Number
    • F0036
    • F0036W1
    • Exp 08/31/2013
    • F0038
    • Exp 06/30/2014
    • F0039
    • Exp 08/31/2014
Amount recalled
70,006 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 photo curing 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, 6:29 PM UTC

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