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FDAFDA · Food and drugs·Recall number D-336-2014

Stalevo (carbidopa, levodopa, and entacapone) 12.5/50/200 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only, Manufactured by: Novartis Pharma Productions GmbH Wehr, Germany. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9407-01

Published December 18, 2013 · Recall initiated: August 8, 2013

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Novartis Pharmaceuticals Corp.
Distributor
Nationwide and Puerto Rico
Lot
Product code: 707156; Lot Number: F0012, Exp 02/28/2014
Risk classification
Class II
Area (FDA)
drug
Country
United States

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