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Recall Observatory FDA recall evidence

Drug product

Exforge (amlodipine and valsartan Tablets) 5/320 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 # 0078-9490-07

D-329-2014

August 08, 2013

Class II

Product summary

Firm
Novartis Pharmaceuticals Corp.
Event
Event 66015
Status
Terminated
Classification
Class II
Quantity
869,951 bottles
Official record key
drug-enforcement:D-329-2014

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: 710003; Lot Number: F0102, Exp 11/30/2013; F0115, F0116, Exp 01/31/2014; F0105, F0109, F0111, F0112, Exp 02/28/2014; F0121, F0122, Exp 05/31/2014; F0125A, F0125W1, Exp 07/31/2014; F0137, F0139, F0140, F0141, F0142, F0144; Exp 11/30/2014

Distribution pattern: Nationwide and Puerto Rico

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Chemical Contamination