Reported Dec 18, 2013 · Terminated
Lescol XL (fluvastatin sodium) Extended-Release Tablets, 80 mg per tablet, 7 tablets per bottle, Physician Sample-Not…
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?
- Lescol XL (fluvastatin sodium) Extended-Release Tablets, 80 mg per tablet, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only
- Manufactured byNovartis Pharma Stein AG Stein, Switzerland
- Distributed by
Novartis Pharmaceuticals Corp. East HanoverNew Jersey 07936NDC # 0078-9354-07
- Lot codes and dates
- Product code707136
- Lot Number
F0017Exp 01/31/2015
- Amount recalled
- 46,812 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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