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 |