FDA warns of mold in recalled specialty drugs
Tuesday, March 19, 2013
WASHINGTON (AP) — The Food and Drug Administration warned doctors and hospital managers Monday about a nationwide recall of all drugs made by a New Jersey compounding pharmacy because of possible mold contamination.
The recalled products from Med Prep Consulting Inc. include dozens of antibiotics, pain relievers and drugs used in surgery and labor. The drugs were packaged in infusion bags, plastic syringes and glass vials and distributed to regional hospitals in New Jersey, Pennsylvania, Connecticut and Delaware.
Tinton Falls, N.J.-based Med Prep said Saturday that mold was found in five bags of magnesium sulfate dispensed to a Connecticut hospital. Magnesium sulfate is used to control seizures and premature labor in pregnant women.
Med Prep is a compounding pharmacy, which means it mixes custom formulations of drugs to meet doctors’ specifications. The recall marks the second time in less than a year that a compounding pharmacy has recalled all of its products because of contamination.
A tainted steroid distributed last year by a Massachusetts-based compounding pharmacy killed 50 people and has sickened more than 720 nationwide. Many of the cases involved a rare form of meningitis tied to fungus found in the New England Compounding Center’s facilities. The company has been shut down since the outbreak was discovered in September.
In recent weeks the FDA has stepped up inspections of compounding pharmacies across a dozen states.
No injuries have been reported to date from Med Prep products, but the FDA says it is working with officials in New Jersey and Connecticut to determine the scope of contamination.
“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,” Janet Woodcock, director of the FDA’s drug center, said in a statement.
The New Jersey State Board of Pharmacy reached an agreement with the company on Friday to shut down all production and shipping of medications.
Med Prep produces liquid drug formulations that given to patients intravenously.
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