The recall affects the following products:
- Leucovorin calcium injection, 500mg SDV – Lot# 2017620; Exp. Date 1/31/2013 and Lot #2038374; Exp. Date 2/28/2013
- Leucovorin calcium injection, 500mg SDV NOVA PLUS – Lot# 2038374A; Exp. Date 2/28/2013
The recall is being conducted due to the discovery of visible crystalline particulate matter in a small number of vials. The particulate matter has been identified as active drug substance and as a potential health hazard. Adverse reactions may include vein irritation and phlebitis, clinically occult pulmonary granulomas detected at routine autopsy examination, local tissue infarction, severe pulmonary dysfunction, occlusion of capillaries and arteries, anaphylactic shock and death.
Leucovorin calcium, a folic acid derivative, is indicated in rescue treatment after high-dose methotrexate therapy in osteosarcoma, megalobastic anemia due to folic acid deficiency when oral therapy is not feasible, and palliative treatment of advanced colorectal cancer in combination with 5-fluorouracil.
For more information call (800) 521-5169 or visit www.bedfordlabs.com.