In July 2012, Bedford Laboratories announced the nationwide voluntary recall of two lots of Leucovorin Calcium Injection due to a field product complaint in which visible crystalline particulate matter was found in a small number of vials within the identified lots. This recall was broadened to include all lots of Leucovorin Calcium Injection within expiry that have been distributed due to the potential for crystalline particulate matter in these lots.
The recall now affects the following products:
- Leucovorin Calcium Injection, 500mg SDV – Lot # 2017619 (exp. date 6/30/13), 2017621 (exp. date 1/31/13), 2038375 (exp. date 3/31/13), 2065418 (exp. date 6/30/13), 2067176 (exp. date 6/30/13), 2067177 (exp. date 6/30/13)
- Leucovorin Calcium Injection, 500mg SDV NOVA PLUS – Lot # 2067178A (exp. date 6/30/13)
Leucovorin Calcium, a folic acid derivative, is indicated in rescue treatment after high-dose methotrexate therapy in osteosarcoma, megalobastic anemia due to folic acid deficiency when oral therapy is not feasible, and palliative treatment of advanced colorectal cancer in combination with 5-fluorouracil.
For more information call (800) 521-5169 or visit www.bedfordlabs.com.