Med Prep Consulting, Inc., is voluntarily recalling all lots of all products compounded at its facility. The recall resulted from the pharmacy being notified by a Connecticut hospital, that it observed visible particulate contaminants in 50 ml bags of intravenous solution labeled “MAGNESIUM SULFATE 2GM IN DEXTROSE 5% IN WATER, 50ML FOR INJECTION.” The visible particulate contaminants were confirmed to be mold. These were unique and distinct lots compounded and dispensed by the pharmacy to the Connecticut hospital. Five contaminated bags have been discovered so far. The pharmacy included all compounded products in the voluntary recall due to lack of sterility assurance.
Administration of an intravenous product found to be contaminated with mold, could result in a fatal infection in a broad array of patients. To date, no injuries or illnesses have been reported.
The products are used for a wide range of therapeutic uses for hospitalized patients and outpatients, and, patients directly treated by a health care professional at a physician’s office practice facility or clinic. None of these products are dispensed directly to patients from retail pharmacies or to home care patients for either self-administration or nursing administration.
All products are packaged in plastic infusion bags, plastic infusion devices, plastic syringes and glass vials. The products 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. All of these products were distributed through March 13, 2013, from Tinton Falls, New Jersey.
See the Recall