D-337-2014 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 18, 2013
- Initiation Date
- August 8, 2013
- Termination Date
- December 21, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,6245 bottles
Product Description
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
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 photocuring agent used in inks on shrink-wrap sleeves.
Distribution Pattern
Nationwide and Puerto Rico
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