D-340-2014 Class II Terminated
FDA drug recall D-340-2014 was initiated by Novartis Pharmaceuticals Corp. on Aug 8, 2013 and is designated Class II. 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… The recall status is terminated (terminated Dec 21, 2015). Affected quantity: 70,006 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Dec 18, 2013
- Initiation Date
- Aug 8, 2013
- Termination Date
- Dec 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.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-340-2014
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026