FDAFDA · Food and drugs·Recall number D-329-2014
Exforge (amlodipine and valsartan Tablets) 5/320 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 # 0078-9490-07
Published December 18, 2013 · Recall initiated: August 8, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Novartis Pharmaceuticals Corp.
- Distributor
- Nationwide and Puerto Rico
- Lot
- Product code: 710003; Lot Number: F0102, Exp 11/30/2013; F0115, F0116, Exp 01/31/2014; F0105, F0109, F0111, F0112, Exp 02/28/2014; F0121, F0122, Exp 05/31/2014; F0125A, F0125W1, Exp 07/31/2014; F0137, F0139, F0140, F0141, F0142, F0144; Exp 11/30/2014
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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