drugs Class II Updated 2013-12-18

Novartis Pharmaceuticals Corp. recalls Exforge (amlodipine and valsartan Tablets) 10/160 mg, Rx onl

Recalled Product

Exforge (amlodipine and valsartan Tablets) 10/160 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9489-07

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: 710011; Lot Number: F0060, Exp 01/31/2014; F0028A, Exp 02/28/2014; F0061, Exp 03/31/2014; F0062, Exp 05/31/2014; F0033A, Exp 10/31/2014; F0037A, Exp 01/31/2015
View official government recall

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