drugs Class II Updated 2013-12-18

Novartis Pharmaceuticals Corp. recalls Exforge (amlodipine and valsartan, Tablets) 10/320 mg, Rx on

Recalled Product

Exforge (amlodipine and valsartan, Tablets) 10/320 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 # 0078-9491-07

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: 710007 & 725277; Lot Number: F0131, Exp 11/30/2013; F0138, Exp 01/31/2014; F0137, F0139, F0140, F0141, F0142, F0142A, Exp 02/28/2014; F0145, F0150, F0157, F0158, Exp 04/30/2014; F0159, F0160, Exp 05/31/2014; F0163, F0165, Exp 07/31/2014; F0184, Exp 01/31/2015
View official government recall

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