Bristol-Myers Squibb Initiates Voluntary Recall of 10 Lots of BiCNU (carmustine for injection) Due to the Potential for Overfill

PRINCETON, N.J., August 30, 2012 - Bristol-Myers Squibb Company (NYSE: BMY) has initiated a voluntary recall nationwide of 10 lots of BiCNU® (carmustine for injection) previously manufactured by Ben Venue Laboratories, Inc., a former, third-party contract manufacturer for the company, to the user level. The precautionary recall of BiCNU, a chemotherapeutic agent administered to patients in a hospital or other clinical setting, is being 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.

BiCNU is used as a therapy for treatment of brain tumors, multiple myeloma, Hodgkin’s disease and non- Hodgkin’s lymphoma. Potential adverse events include myelosuppression, pulmonary toxicity and renal abnormality, as well as increased incidence of other adverse events known to be caused by carmustine. In the Hematopoietic Stem Cell Transplantation (HSCT) setting, which has been reported as an off-label use, BiCNU is administered using a high dose regimen and this may lead to fatal outcomes in certain individuals.

This recall is being conducted in the U.S., Canada and countries within Europe, Latin America and Asia-Pacific for lots previously manufactured by Ben Venue. Bristol-Myers Squibb does not anticipate a product shortage resulting from the recall as current supply is secured through another manufacturer.

Bristol-Myers Squibb is committed to ensuring patient safety and is working to resolve this issue quickly and appropriately. The company is notifying regulatory authorities in impacted countries and is issuing recall communications to hospitals and health care professionals who may have received product from recalled lots.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program online, by regular mail, or by fax.

Online: www.fda.gov/medwatch/report.htm Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form. Fax: 1-800-FDA-0178

This recall is for the following lots of BiCNU distributed between March 2010 and July 2011. Hospitals and health care professionals who have received the indicated lots are directed to cease use immediately and contact the Bristol-Myers Squibb Company recall coordinator to arrange return of all remaining inventory.

Patient Kit Lot Number

Item Description

Expiration

9L7003A

BiCNU® (carmustine for injection) 100 mg per vial, 50mg/mL

Nov 2012

9H4209A

BiCNU® (carmustine for injection) 100 mg per vial, 50mg/mL

Jan 2013

9H4211A

BiCNU® (carmustine for injection) 100 mg per vial, 50mg/mL

Feb 2013

0B7004A

BiCNU® (carmustine for injection) 100 mg per vial, 50mg/mL

Apr 2013

0B7005A

BiCNU® (carmustine for injection) 100 mg per vial, 50mg/mL

May 2013

0E7004A

BiCNU® (carmustine for injection) 100 mg per vial, 50mg/mL

May 2013

0E7006A

BiCNU® (carmustine for injection) 100 mg per vial, 50mg/mL

Sep 2013

0J7007A

BiCNU® (carmustine for injection) 100 mg per vial, 50mg/mL

Jan 2014

1A7005A

BiCNU® (carmustine for injection) 100 mg per vial, 50mg/mL

Jan 2014

1C7006A

BiCNU® (carmustine for injection) 100 mg per vial, 50mg/mL

Apr 2014

These lots represent all remaining lots of BiCNU manufactured at Ben Venue Laboratories within expiration. This voluntary recall is only for the lots listed. No other lots of BiCNU are subject to this recall.

Health care professionals and customers may call the following for assistance if they have further questions about the recall:

Recall Logistics

GENCO Pharmaceutical Services 1-888-896-4564

The line is available Mon-Fri, 7:00 AM – 5:00 PM CST.

General and Medical Inquiries

Bristol-Myers Squibb Customer Information Center 1-800-332-2056

The line is available Mon-Fri, 8:00 AM – 8:00 PM EST.

U.S. Reimbursement Process

Bristol-Myers Squibb Customer Service Operations 1-800-631-5244 (option 5)

Puerto Rico Reimbursement Process

1-787-792-6624 (Puerto Rico only)

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit www.bms.com or follow us on Twitter at http://twitter.com/bmsnews.

Contacts:
Media: Ken Dominski, 609-252-5251, ken.dominski@bms.com

Posted: August 2012


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