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Med Prep Consulting Inc. Compounded Products: Recall - Potential Mold Contamination
AUDIENCE: Risk Manager, Pharmacy, Family Practice
ISSUE: Med Prep Consulting, Inc. notified the public that it is recalling all lots of all products compounded at its facility, due to lack of sterility assurance. The level of recall is to the user: regional hospital pharmacies and related departments, and physician’s office practices. The recall resulted from the pharmacy being notified by a Connecticut hospital that it observed visible particulate contaminants in 50 ml bags of MAGNESIUM SULFATE 2GM IN DEXTROSE 5% IN WATER, 50ML FOR INJECTION intravenous solution, confirmed to be mold. These were unique and distinct lots compounded and dispensed by the pharmacy to the Connecticut hospital. At this time a total of five (5) contaminated bags were discovered. See the Med Prep Press Release for a list of affected products.
Administration of an intravenous product found to be contaminated with mold could result in a fatal infection in a broad array of patients.
BACKGROUND: The affected products are used for a wide range of therapeutic uses for hospitalized inpatients 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. 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. All of these products were distributed to the described users through March 13, 2013, from Tinton Falls, New Jersey to both regional and nationwide locations.
RECOMMENDATION: All facilities that received any product compounded by Med Prep Consulting, Inc. have been notified by telephone fax, electronic mail and regular mail of the recall and have been instructed to remove and return the product to the pharmacy. Facilities with questions may contact the company at 732-493-3390, Monday through Friday, between 10:00 a.m. and 5:00 p.m. EST.
Read the MedWatch safety alert, including a link to the Press Release, at:
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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