Reported Dec 18, 2013 · Terminated

Exforge (amlodipine and valsartan Tablets) 5/320 mg, Rx only 7 tablets per bottle, Physician Sample - Not For Sale.…

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 (amlodipine and valsartan Tablets) 5/320 mg, Rx only 7 tablets per bottle, Physician Sample - Not For Sale
  • Manufactured byNovartis Pharma Stein AG Stein, Switzerland
  • Distributed byNovartis Pharmaceuticals Corp. East Hanover, New Jersey 07936 - NDC # 0078-9490-07
Lot codes and dates

8 of 8 products

Products covered by this recall
Model / numberProduct as published
710003
Lot Number: F0102, Exp 11/30/2013
F0115, F0116, Exp 01/31/2014
F0105, F0109, F0111, F0112, Exp 02/28/2014
F0121, F0122, Exp 05/31/2014
F0125A, F0125W1, Exp 07/31/2014
F0137, F0139, F0140, F0141, F0142, F0144
Exp 11/30/2014
Amount recalled
869,951 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, 5:51 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.