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Leucovorin Calcium Injection (Bedford Laboratories): Recall - Visible Particulate Matter
AUDIENCE: Pharmacy, Risk Manager, Oncology
ISSUE: Bedford Laboratories issued a nationwide recall of three lots of Leucovorin Calcium Injection, due to the discovery of visible crystalline particulate matter in a small number of vials. To date, there have been no reports of any adverse events for the lots being recalled. 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.
See the Press Release for a listing of lot numbers affected. The shipping dates for these recalled lots were between January 2011 and June 2011.
BACKGROUND: Leucovorin Calcium rescue is indicated after high‐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 5‐fluorouracil to prolong survival in the palliative treatment of patients with advanced colorectal cancer.
RECOMMENDATION: Healthcare practitioners who had received the lot were instructed not to use the product and immediately quarantine it for return. As stated in the Product Package Insert, “Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.”
Read the MedWatch safety alert, including a link to the Press Release, at:
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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