AuroMedics Issues Voluntary Nationwide Recall of Pantoprazole Sodium for Injection 40 Mg per Vial

AuroMedics Pharma is voluntarily recalling one lot of Pantoprazole Sodium for Injection 40 mg per vial, to the hospital level. The product was found to contain glass particles in the vial.  This problem was discovered as a result of a product complaint in which the contents of one vial from one batch was found to contain a piece of glass.

The administration of a glass particulate, if present in an intravenous drug, may result in local irritation or swelling in response to the foreign material. More serious potential outcomes would include blockage and clotting in blood vessels, which may be life-threatening. To date, AuroMedics Pharma has not received reports of any adverse events or identifiable safety concerns attributed to this recall.