Med Prep Consulting, Inc. is voluntarily recalling all lots of Magnesium Sulfate 2 grams in Dextrose 5% for Injection products compounded at its facility. The level of recall is to the user, that is, regional hospital pharmacies and related departments. 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. At the time of this recall, there is no indication that the sterility of the magnesium sulfate products that the pharmacy dispensed to twelve other facilities was compromised. Nonetheless, in an abundance of caution, the pharmacy included all magnesium sulfate products in the voluntary recall.
Administration of an intravenous product found to be contaminated with mold, could result in a fatal infection in broad array of patients. To date, no injuries or illnesses have been reported.
The product is used for Magnesium electrolyte replacement for hospitalized patients. It is packaged in plastic infusion bags. It is distributed directly to regional hospital pharmacies. This product was distributed regionally to hospital pharmacies from February 18, 2013 through March 13, 2013, from Tinton Falls, New Jersey to Connecticut and other New Jersey locations.
All facilities that received magnesium sulfate products compounded by Med Prep Consulting, Inc. have been notified 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 thru Friday, between 10:00 a.m. and 5:00 p.m. EST.
This recall is being conducted with the knowledge of the US Food and Drug Administration and the New Jersey State Board of Pharmacy.
Product complaints related to this recall should be reported to 732-493-3390, Monday thru Friday, between 10:00 a.m. and 5:00 p.m. EST.
Adverse events that may be related to the use of these products may be reported to FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax:
- Online: www.fda.gov/medwatch/report.htm
- Regular Mail: use postage-paid FDA form 3500 available at:
www.fda.gov/MedWatch/getforms.htm. - Mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787
- Fax: 1-800-FDA-0178
