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Jennifer Markarian is manufacturing editor of BioPharm International.
The New Jersey-licensed specialty pharmacy recalls magnesium sulfate products and halts all production operations.
FDA alerted healthcare providers and patients of a voluntary, nationwide recall of all sterile drug products from Med Prep Consulting, a specialty compounding pharmacy licensed by the state of New Jersey, in a March 18, 2013 FDA press release. Med Prep Consulting initiated the recall because fungus particles were identified in bags of magnesium sulfate intravenous solution after healthcare providers at a hospital in Connecticut observed the floating particles. The New Jersey State Board of Pharmacy entered into an interim voluntary consent order with Med Prep Consulting, under which the company temporarily halted all production operations.
“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, in the press release. “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.” FDA’s investigation is ongoing, and 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.
Med Prep Consulting’s Tinton Falls, NJ facility prepares sterile products for intravenous administration in hospitals and physician’s offices or clinics.
Last year’s fatal fungal meningitis outbreak was attributed to lack of sterility assurance in injectable products produced by a compounding pharmacy in Massachusetts.