Recalls / Class II

Class IID-331-2014

Product

Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/12.5 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 # 0078-9559-89

Affected lot / code info

Product code: 715523 & 725278; Lot Number: F0019, F0019A, Exp 08/31/2013; F0020, Exp 09/30/2013; F0021, F0021A, Exp 10/31/2013; F0022, F0025, Exp 11/30/2013; F0024, F0026, Exp 12/31/2013; F0027, Exp 09/30/2014

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

328,543 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-331-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.