FDA NEWS RELEASE: FDA alerts health care providers of recall of all sterile drug products by Med Prep Consulting in New Jersey
For Immediate Release: March 18, 2013
The U.S. Food and Drug Administration is alerting health care providers and patients of a voluntary nationwide recall of all lots of all products produced by Med Prep Consulting Inc. of Tinton Falls, N.J., a specialty pharmacy licensed by the state of New Jersey. The recall was announced after health care providers at a hospital in Connecticut observed floating particles, later identified to be a fungus, in five bags of magnesium sulfate intravenous solution.
The magnesium sulfate products may have been distributed to additional facilities in Connecticut, New Jersey, Pennsylvania, and Delaware. Until further notice, health care providers should stop using all products made by Med Prep Consulting Inc. and return them to the company.
"Giving a patient a contaminated injectable drug could result in a life-threatening infection," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "We do not have reports of patient infections. However, due to a lack of sterility assurance at the facility and out of an abundance of caution, this recall is necessary to protect patients."
This investigation is ongoing. The FDA is working with the Centers for Disease Control and Prevention and state officials in New Jersey and Connecticut to determine the scope of the contamination. The level of recall is to the user level, this includes regional hospital pharmacies and related departments, and physician's office practices. This recall includes all products distributed through March 15, 2013.
In addition to the recall, on March 15, 2013, the New Jersey State Board of Pharmacy entered into an Interim Voluntary Consent Order with Med Prep Consulting Inc. Under the Order, the firm has temporarily halted all production operations, including the processing and shipping of medications.
Med Prep Consulting Inc. prepares a number of sterile products for intravenous administration for a number of medical conditions. The firm's products include antibiotics, general and local anesthetics, cardiac, labor and delivery and pain management medications.
To date, the FDA is not aware of any reports of injury or illness associated with the recalled magnesium sulfate intravenous solution. The FDA asks health care professionals and consumers to report any adverse reactions to the FDA's MedWatch program:
- Complete and submit the report online at www.fda.gov/medwatch/report.htm
- Download and complete the form, then submit it via fax at 1-800-FDA-0178
Health care providers with questions may contact Med Prep at 732-493-3390, Monday through Friday, between 10 a.m. and 5 p.m. EST.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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