Home / Recalls / Novartis Pharmaceuticals Corp. / D-335-2014

D-335-2014 Class II Terminated

Recalled by Novartis Pharmaceuticals Corp. — Suffern, NY

Recall Details

Product Type
Drugs
Report Date
December 18, 2013
Initiation Date
August 8, 2013
Termination Date
December 21, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
46,812 bottles

Product Description

Lescol XL (fluvastatin sodium) Extended-Release Tablets, 80 mg per tablet, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9354-07

Reason for Recall

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.

Distribution Pattern

Nationwide and Puerto Rico

Code Information

Product code: 707136; Lot Number: F0017, Exp 01/31/2015

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