Voluntary Recall Of Leucovorin Calcium Injections

The pharmaceutical company Bedford Laboratories, which is a subsidiary of Ben Venue Laboratories, has issued a nationwide voluntary recall of all hospital and user level products of Leucovorin calcium injections.  So far, the only applicable batches of the injection that are being recalled by the company are the Leucovorin calcium injection dosage of 500mg SDV Bedford label and the 500mg SDV NOVA PLUS ® label.  It is worth noting that no other lots of the injections that have been sold are subject to the recall.

The recall is being undertaken due to the discovery of visible crystalline particle matter in a small number of vials within the lots mentioned before.  The substance has been distinguished as an active drug substance and isn’t a foreign material and is not a contaminant.  Its been regarded as a potential health hazard which can induce adverse reactions that include vein irritation, phlebitis, clinically occult pulmonary granulomas which can be detected at autopsy exams, severe lung dysfunction, tissue infarction, occlusion of capillaries or arteries, anaphylactic shock and even in some cases death.

Leucovorin calcium rescue is usually indicated after a high dosage methotrexate therapy for osteosarcoma.  It is also indicated for diminishing toxicity and to counteract effects of impaired methotrexate elimination and overdose of folic acid antagonists, the treatment of megaloblastic anemias from a folic acid deficiency usually when it isn’t feasible to pursue an oral therapy, and for use in combination with 5-fluororacil to prolong survival in the palliative treatment of patients who’ve got advanced colorectal cancer.

Healthcare practitioners and customers who have received the product from the lots are being notified to quarantine these products immediately.