MedPrep Consulting Inc. announced that it is recalling all lots of all products compounded at its facility due to lack of sterility assurance. The recall resulted after the pharmacy was notified by a Connecticut hospital that it observed visible particulate contaminants in magnesium sulfate 2g in dextrose 5% in water, 50mL for injection intravenous solution that was confirmed to be mold. Magnesium sulfate is used for magnesium electrolyte replacement for hospitalized patients.
Administration of an intravenous product with mold contamination could result in a fatal infection in a wide range of patients. As a precaution, the pharmacy included all compounded products in the voluntary recall.
Products packaged in plastic infusion bags, plastic infusion devices, plastic syringes and glass vials were distributed directly to regional hospital pharmacies located in New Jersey, Pennsylvania, Connecticut, and Delaware. Products packaged in plastic syringes only, were distributed nationwide to physician’s office practice facilities and clinics. A full list of affected products can be found here.
For more information call (732) 493-3390 or visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm344259.htm.