Bristol-Myers Squibb: Company Statement on BiCNU® (carmustine for injection)
 

Company Statement on BiCNU® (carmustine for injection)

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 has globally recalled all lots of BiCNU® (carmustine for injection) previously manufactured by Ben Venue Laboratories, Inc., a former, third-party contract manufacturer for the company. This recall does not impact BiCNU manufactured by Emcure Pharmaceuticals, Ltd., the current manufacturer. Bristol-Myers Squibb does not anticipate a product shortage resulting from the recall.

The precautionary recall of BiCNU, a chemotherapeutic agent administered to patients in a hospital or other clinical setting, was initiated following the discovery of one overfilled vial of BiCNU during routine testing. An overfilled vial of BiCNU represents a significant risk to patients due to the nature of product administration and could result in patients receiving a dose greater than prescribed. There have been no reported adverse events associated with this issue.

Countries included in this recall are Argentina, Australia, Austria, Brazil, Bulgaria, Canada, Chile, Czech Republic, Denmark, Ecuador, Finland, Germany, Hong Kong, Hungary, Netherlands, New Zealand, Norway, Peru, Russia, Slovenia/Croatia, Sweden, Taiwan, Thailand, U.S., Venezuela.

Bristol-Myers Squibb is committed to ensuring patient safety and is working to resolve this issue quickly and appropriately. The company has notified regulatory authorities in impacted countries and has issued recall communications to hospitals and health care professionals.

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

Country

Contact Numbers

Argentina

(011) 4789-8558 / 8431

Australia

1800 629 273

Austria

+43-1-601430

Brazil

0800 772 1291

0800 727 6160

0800 770 8801

Chile

798-9200 ext. 1741 123-0-020-5542

562 3400412

Croatia +385 98 9806 806

Czech Republic

+420-221016153 +420-602166384

Denmark

+45 3065 5576

Finland

+ 358 50 4491002 + 358 50 4493119

Germany

089 - 12142-350

Hungary

(+36)1-301-9707 (+36)-305670590

Netherlands

+31 (0) 348.574.231 +31 (0) 6.51073792

New Zealand

0800 804080

Norway

+45 30 65 55 76

Peru

411-6200 ext. 2995 0800-77-139

711-7000 extension 7331

Russia

+7(495)786-71-08

Slovenia +386(1)236 47 00 or
+386 (0)1 200 30 79

Sweden

+46 70-266 40 82

Taiwan /Hong Kong • Ms. Doris Chou (Safety)
Office: +886-2-2756-1106
Cell: +886-978-179-933
• Mr. Fred Liu (Quality)
Office:+886-2-27561260
Cell:+886-988-753-982

Thailand

+66 2 725 1443

United States

1-888-896-4564

1-800-332-2056

Venezuela

212-300-5380 0800-102 9107 212-3005316 / 212-3005317

 
 
 
 


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