The following Leucovorin Calcium Injection, 500mg, lots are involved:
Leucovorin Calcium Injection, 500mg: SDV Bedford Label
- NDC 55390‐009‐01
- Package size, 1 pack
- Lot number and expiration 2017620‐1/31/2013 and 2038374‐2/28/2013
- First ship date 1/31/2011 5/17/2011
- Last ship date 2/24/2011 6/15/2011
Leucovorin Calcium Injection, 500mg: SDV NOVA PLUS® Label
- NDC 55390‐826‐01
- Package size, 1 pack
- Lot number and expiration 2038374A – 2/28/2013
- First ship date 5/16/2011
- Last ship date 6/29/2011
This nationwide recall follows the discovery of visible crystalline particulate matter in a small number of vials within the recalled lots. The discovery was made due to a field product complaint for visible crystalline particulate and discovery of crystalline particulate in a retained sample. 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 a foreign material or contamination and 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 following high-dose methotrexate therapy in osteosarcoma, to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent folic acid antagonists overdose of, 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.
Notification of this recall is being sent to customers and health care practitioners who received the recalled product; health care practitioners were instructed not to use the product and were advised to immediately quarantine the product for return.
Bedford Laboratories’ Client Services can be reached, toll-free, at 1.800.562.4797 between 8:00 a.m. and 5:00 p.m., Eastern Time (ET), Monday through Friday. Any adverse reactions should be reported to Bedford Laboratories, toll-free, at 1.800.521.5169. Adverse reactions or quality problems may also be reported to the FDA’s MedWatch Adverse Event Reporting program. The form and information can be accessed at www.fda.gov/medwatch/report.htm.
Bedford Laboratories is in contact with the FDA and notes that, as is standard practice, and 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.”