Recalls / Class II

Class IID-328-2014

Product

Exforge (amlodipine and valsartan Tablets) 5/160 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 # 0078-9488-07

Affected lot / code info

Product code: 709999 & 725275; Lot Number: F0048A, Exp 08/31/2013; F0056A, Exp 10/31/2013; F0084, F0085, Exp 01/31/2014; F0059A, F0088, Exp 02/28/2014; F0086, F0087, Exp 03/31/2014; F0061A, F0063W1, Exp 05/31/2014; F0070A, Exp 09/30/2014; F0082A, Exp 02/28/2015

Why it was recalled

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.

Recalling firm

Firm

Novartis Pharmaceuticals Corp.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

25 Old Mill Rd, Suffern, New York 10901-4106

Distribution

Quantity

1,492,475 bottles

Distribution pattern

Nationwide and Puerto Rico

Timeline

Recall initiated

2013-08-08

FDA classified

2013-12-06

Posted by FDA

2013-12-18

Terminated

2015-12-21

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-328-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.