Bedford Laboratories in informing hospitals and providers of a recall of three lots of Leucovorin Calcium Injection. This voluntary recall is being conducted due to the discovery of visible crystalline particulate matter in a small number of vials within the lots listed in the company press release which is provided in references below. The particulate matter has been identified as active drug substance and not foreign material or contamination. Particulate matter has been recognized 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 rescue is indicated after highâ€dose methotrexate therapy in osteosarcoma. Leucovorin Calcium is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosages of folic acid antagonists; the treatment of megaloblastic anemias due to folic acid deficiency when oral therapy is not feasible; and for use in combination with 5â€fluorouracil to prolong survival in the palliative treatment of patients with
advanced colorectal cancer.
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