Home / Recalls / Novartis Pharmaceuticals Corp. / D-340-2014

D-340-2014 Class II Terminated

Recalled by Novartis Pharmaceuticals Corp. — Suffern, NY

Recall Details

Product Type
Drugs
Report Date
December 18, 2013
Initiation Date
August 8, 2013
Termination Date
December 21, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
70,006 bottles

Product Description

Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets 300/25 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only, Manufactured by: Novartis Pharma Productions GmbH Wehr, Germany. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9524-89

Reason for Recall

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 photo curing agent used in inks on shrink-wrap sleeves.

Distribution Pattern

Nationwide and Puerto Rico

Code Information

Product code: 712427; Lot Number: F0036, F0036W1, Exp 08/31/2013; F0038, Exp 06/30/2014; F0039, Exp 08/31/2014.

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