Bedford recalls leucovorin calcium injection at hospital/user-level
Bedford Laboratories has issued a nationwide voluntary hospital/user-level recall of certain lots of leucovorin calcium injection due to the discovery of visible crystalline particulate matter in a small number of vials.
The particulate matter, which has been recognized as a potential health hazard, was identified as active drug substance and not foreign material or contamination.
Vein irritation and phlebitis, clinically occult pulmonary granulomas detected at routine autopsy examination, local tissue infarction, pulmonary dysfunction, occlusion of capillaries and arteries, anaphylactic shock and death may be the possible adverse reactions due to the particulate matter.
Leucovorin Calcium is indicated after high-dose methotrexate therapy in osteosarcoma and also to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosages of folic acid antagonists.
Leucovorin Calcium is also used for the treatment of megaloblastic anemias due to folic acid deficiency when oral therapy is not feasible and for use in combination with 5-fluorouracil to prolong survival in the palliative treatment of patients with advanced colorectal cancer.