Reported Dec 18, 2013 · Terminated
Exforge (amlodipine and valsartan, Tablets) 10/320 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) 10/320 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 HanoverNew Jersey 07936NDC # 0078-9491-07
- Lot codes and dates
8 of 8 products
Products covered by this recall Model / number Product as published 710007& 725277 — Lot Number: F0131, Exp 11/30/2013 — F0138, Exp 01/31/2014 — F0137, F0139, F0140, F0141, F0142, F0142A, Exp 02/28/2014 — F0145, F0150, F0157, F0158, Exp 04/30/2014 — F0159, F0160, Exp 05/31/2014 — F0163, F0165, Exp 07/31/2014 — F0184, Exp 01/31/2015 - Amount recalled
- 951,109 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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