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In a press release by the FDA, a voluntary recall is being conducted by the Bedford Laboratories, after the discovery of a “visible crystalline particulate matter” in a limited number of vials within these different lots:

  • Leucovorin Calcium Injection- 500mg SDV Bedford Label- Lot# 2017620‐1/31/2013 2038374‐2/28/2013
  • Leucovorin Calcium Injection- 500mg SDV NOVA PLUS® Label- Lot# 2038374A – 2/28/2013

The discovery was identified as an active drug substance, and not, in fact, a foreign material or contamination. Naturally, this is incredibly troublesome and problematic for Bedford Laboratories.

The particulate matter has been declared a potential health hazard, with adverse reactions which may include: “some vein irritation or phlebitis, as well as clinically occult pulmonary granulomas detected around the routine autopsy examination, local tissue infarction, severe pulmonary dysfunction, occlusion of the capillaries and arteries, and anaphylactic shock or death.”

Leucovorin Calcium rescue is indicated after high-dose methotrexate therapy in osteosarcoma. The drug is meant to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosages of folic acid antagonists. It is part of an oral therapy, and for use in combination with 5-fluorouracil to prolong survival in the palliative treatment of patients with advanced colorectal cancer.

Any adverse reactions experienced with the lot reported in this release should be reported to Bedford Laboratories at 800-521-5169 between the hours of 8 am to 5 pm during normal business days.

Find out more here: http://www.fda.gov/Safety/Recalls/ucm310666.htm