Magnesium sulfate injection by Fresenius Kabi USA: Recall – Glass particles in vials

Safety IV catheter

Intravenous products: FDA report “Fresenius Kabi USA notified health professionals of a voluntary recall of one lot – Lot 6103882 – of Magnesium Sulfate Injection, USP due to the potential presence of glass particles in the vials. The recalled product is labeled with Product Code 6450 and packaged as 500mg/mL strength in 50mL glass vials (25 vials per tray). The product was shipped in the United States between May 30, 2012 and June 6, 2012 and has an expiration date of October 31, 2014.

The administration of glass particulate, if present in a parenteral drug, can lead to sequelae of thromboembolism, some life-threatening (such as pulmonary emboli); phlebitis, mechanical block of the capillaries or arterioles; activation of platelets; and subsequent generation of microthrombi. Patients with preexisting condition of trauma or other medical condition that adversely affects the microvascular blood supply are at an increased risk. Administration of a glass particulate can also lead to formation of granulomas, a protective local inflammatory response to the foreign material.”

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