drugs Class II Updated 2013-12-18

Novartis Pharmaceuticals Corp. recalls Lescol XL (fluvastatin sodium) Extended-Release Tablets, 80

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Product code: 707136; Lot Number: F0017, Exp 01/31/2015
View official government recall

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