[COLOR="#000000"]Bristol-Myers Squibb Company 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.[/color]