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Recall Observatory FDA recall evidence

Drug 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

D-331-2014

August 08, 2013

Class II

Product summary

Firm
Novartis Pharmaceuticals Corp.
Event
Event 66015
Status
Terminated
Classification
Class II
Quantity
328,543 bottles
Official record key
drug-enforcement:D-331-2014

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: 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

Distribution pattern: Nationwide and Puerto Rico

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Chemical Contamination