Exforge recall: Contamination
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
Why was Exforge recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- 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
- Recalling firm
- Novartis Pharmaceuticals Corp.
- Quantity
- 1,492,475 bottles
- Distribution
- Nationwide and Puerto Rico
- Recall date
- December 18, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)