Drug product
Tekturna (aliskiren) Tablets 150 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 # 0078-9485-07
D-337-2014
Product summary
- Event
- Event 66015
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12,6245 bottles
- Official record key
drug-enforcement:D-337-2014
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: 708236; Lot Number: F0116, F0116W1, F0016W2, Exp 09/30/2013; F0117, Exp 02/28/2014; F0118, 6) F0119, Exp 08/31/2014
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
Chemical Contamination