Reported Dec 18, 2013 · Terminated
Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/12.5 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) 5/160/12.5 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 # 0078-9559-89
- Lot codes and dates
- Product code715523 & 725278
- Lot Number
F0019F0019AExp 08/31/2013F0020Exp 09/30/2013F0021F0021AExp 10/31/2013F0022F0025Exp 11/30/2013F0024F0026Exp 12/31/2013F0027Exp 09/30/2014
- Amount recalled
- 328,543 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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