Recalls / Class II

Class IID-330-2014

Product

Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 10/320/25 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 # 0078-9563-89

Affected lot / code info

Product code: 715512 & 725276; Lot Number: F0034, Exp 08/31/2013; F0035, F0036, F0036A, Exp 10/31/2013; F0038, F0039, F0040, F0041, F0042, Exp 12/31/2013; F0043, Exp 01/31/2014; F0045, Exp 03/31/2014; F0044, F0046, Exp 04/30/2014

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

281,935 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-330-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.