Potential Glass Particles in Magnesium Sulfate Vials

Fresenius Kabi USA announced a voluntary recall of one lot of Magnesium Sulfate Injection 500mg/mL due to potential glass particles in the vials. Magnesium Sulfate is used as electrolyte replacement therapy in the treatment of magnesium deficiency, and as an anticonvulsant to prevent and control seizures in severe toxemia of pregnancy.

The affected product has lot #6103882, product code 6450, and is packaged in 50mL glass vials (25 vials/tray). The product was shipped in the United States between May 30, 2012 and June 6, 2012 with an expiration of October 31, 2014.

If glass particulate in a parenteral drug is administered to the patient, it can lead to possibly fatal thromboembolism (eg, pulmonary emboli), phlebitis, mechanical block of capillaries or arterioles, activation of platelets, and subsequent generation of microthrombi.

All customers who received the recalled vials are being notified and instructed to return any unused product to their supplier.

For more information call (847) 969-2700 or visit the FDA website.