D-328-2014 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
- 1,492,475 bottles
Product Description
Exforge (amlodipine and valsartan Tablets) 5/160 mg, Rx only 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936 - NDC # 0078-9488-07
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: 709999 & 725275; Lot Number: F0048A, Exp 08/31/2013; F0056A, Exp 10/31/2013; F0084, F0085, Exp 01/31/2014; F0059A, F0088, Exp 02/28/2014; F0086, F0087, Exp 03/31/2014; F0061A, F0063W1, Exp 05/31/2014; F0070A, Exp 09/30/2014; F0082A, Exp 02/28/2015