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
Product summary
- 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
Chemical Contamination