D-337-2014 Class II Terminated
FDA drug recall D-337-2014 was initiated by Novartis Pharmaceuticals Corp. on August 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 contamin… The recall status is terminated (terminated December 21, 2015). Affected quantity: 12,6245 bottles.
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