Bristol-Myers Squibb: Company Statement on VIASPAN®
 
Company Statement on VIASPAN®

As of April 25, 2012
Bristol-Myers Squibb takes the quality and safety of its products very seriously. We are committed to patients’ safety first and to the safest and most effective use of all of our products.


As such, the company recalled all lots of VIASPAN® 50mg/ml manufactured by our contract manufacturer Fresenius Kabi Austria since July 2011.* VIASPAN® is a preservation fluid that is the standard medium for maintaining organs and tissues intended for transplant –from time of procurement to transplantation. The recall was conducted to the retail/dispensing level working with all appropriate health authorities.


The precautionary recall was based on a report that a potential manufacturing issue had been detected during a routine GMP test. Since the implementation of the recall, the company has completed additional tests of product, and while there continues to be no current evidence of product contamination, the company cannot definitively rule out this risk for all lots. Therefore, the current precautionary recall remains.


This precautionary recall was for the countries where alternatives were available in the market including Italy, Estonia, Slovenia, Argentina, Chile, Germany, France, Ireland, and the United Kingdom. In the markets where alternatives were not readily available, Bristol-Myers Squibb has been working with the local health authorities to find alternative solutions for patients and sending Dear Healthcare Provider Letters to physicians including reviews of the benefit/risk for patients. Those countries include Australia, Croatia, Finland, New Zealand, Switzerland, Latvia, Lithuania, Spain, Sweden, Norway, Denmark, Netherlands, and Belgium. At this time, Bristol-Myers Squibb and the local health authorities have found alternatives for patients in Finland, Croatia, Latvia, Lithuania, and Belgium. The Norway Health Authority has decided to postpone recalls pending further testing and to monitor the needs of patients. Bristol-Myers Squibb will continue to work with health authorities in all countries involved to ensure patient safety.


To date, the company has not received any reports of adverse events related to this issue or any complaints of product contamination about the VIASPAN® product that has been released. Bristol-Myers Squibb is committed to ensuring patient safety and is working to resolve this issue quickly and appropriately.


*ViaSpan is marketed by Bristol-Myers Squibb in multiple markets excluding the U.S.

Healthcare professionals and customers in the impacted countries may call the following for assistance if they have further questions about the recall:


Australia

Phone: 1800 067 567
Phone: +61 3 9213 4367

Argentina

Phone: 0800 666 1179

Belgium

Phone: +32 2 352 7172

Chile

Phone: 1230 020 5542

Croatia

Phone: (+385)1 631 1833 or -1837

Denmark

Phone: +45 4593 0506

Estonia

Phone: +37 2 682 7400

Finland

Phone: +358 9 2512 1230

France

Tél: 0810 410 500
Tél: +33 1 58 83 84 96

Germany

Tel: 0800 075 2002
Tel: +49 89 121 42 350

Ireland

Phone: 1 800 749 749
Phone: +35 31291 3800

Italy

Tel: 8008 64184 (solo per l’Italia)
Tel: +39 06 503961

Latvia

Phone: +37 1 67 502 185

Lithuania

Phone: +37 05 279 0762

Netherlands

Phone: +31 348 574 222

New Zealand

Phone: 0800 167 567

Norway

Phone: +47 6755 5350

Slovenia

Phone: +386 1 236 4700

Spain

Tel: 900 150 160

Sweden

Phone: +46 8 704 71 00

Switzerland

Phone: +41 41 767 7200

United Kingdom

Phone: 0800 731 1736
(inside UK only)

 
 
 
 


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