Drug product
Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 10/320/25 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 # 0078-9563-89
D-330-2014
Product summary
- Event
- Event 66015
- Status
- Terminated
- Classification
- Class II
- Quantity
- 281,935 bottles
- Official record key
drug-enforcement:D-330-2014
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: 715512 & 725276; Lot Number: F0034, Exp 08/31/2013; F0035, F0036, F0036A, Exp 10/31/2013; F0038, F0039, F0040, F0041, F0042, Exp 12/31/2013; F0043, Exp 01/31/2014; F0045, Exp 03/31/2014; F0044, F0046, Exp 04/30/2014
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
Chemical Contamination