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Recall Observatory FDA recall evidence

Drug product

Tekturna (aliskiren) Tablets 300 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only. Manufactured by: Novartis Pharma Produktions GmbH Wehr, Germany. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9486-07

D-338-2014

August 08, 2013

Class II

Product summary

Firm
Novartis Pharmaceuticals Corp.
Event
Event 66015
Status
Terminated
Classification
Class II
Quantity
128964 bottles
Official record key
drug-enforcement:D-338-2014

Official wording

Reason: 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.

Code information: Product code: 708239; Lot Number: F0140, F0140W1, Exp 09/30/2013; F0142, Exp 07/31/2014; F0143, Exp 08/31/2014; F0144, Exp 10/31/2014; F0145; Exp 01/31/2015.

Distribution pattern: Nationwide and Puerto Rico

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Chemical Contamination