Tuesday, March 19, 2013

New Jersey compounder issues recall over contaminated IV product.

The AP (3/19) reports that the Food and Drug Administration in an announcement on Monday, informed healthcare providers and hospital managers that a New Jersey compounder, Med Prep Consulting Inc., issued a voluntary recall for its products on Saturday, after determining there was mold in "five bags of magnesium sulfate" IV solutions that were "dispensed to a Connecticut hospital." The New Jersey State Board of Pharmacy "reached an agreement with the company on Friday to shut down all production and shipping" of its products, which 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."

        The Washington Post (3/19, Sun, 489K) notes on its "In the News" summary page that a spokesperson for the New Jersey Pharmacy Board confirmed Tinton Falls, New Jersey-based specialty pharmacy, which "has customers in all 50 states has agreed to stop operations until at least March 22."

        According to the Tennessean (3/18, Wilemon, 120K), the staff at the "Connecticut hospital reported the problem after observing particles floating in an intravenous medicine." In the annoucement, FDA Center for Drug Evaluation and Research Director Dr. Janet Woodcock said, "Giving a patient a contaminated injectable drug could result in a life-threatening infection." Although the agency has not received any "reports of patient infections," Dr. Woodcock said, "Due to the lack of sterility assurance at the facility and out of an abundance of caution, this recall is necessary to protect patients."

        NBC News (3/19, Aleccia) in its "Vitals" blog says that at least 13 "hospitals in Connecticut, Delaware, New Jersey and Pennsylvania apparently received the firm's 50-milliliter bags of magnesium sulfate 2 grams in dextrose 5 percent in water, a solution commonly used to replace vital electrolytes in hospitalized patients, according to agency statements. Product packed in plastic syringes was also distributed nationwide to doctors' offices and clinics, FDA officials said."

        The Newark (NJ) Star-Ledger (3/19, Friedman, 326K) adds that the "affected products were distributed through March 13 to both regional and nationwide locations. A statement posted to the Med Prep's website said no injuries or illnesses had been reported but added, 'administration of an intravenous product found to be contaminated with mold, could result in a fatal infection in a broad array of patients.'"

        Also covering the story are and the Philadelphia Inquirer (3/19, Sell, 306K) "PhillyPharma" blog, which provides a list of all of the products Med Prep Consulting produces, the Asbury Park (NJ) Press (3/19, Bowman), the FOX News (3/18) website and MedPage Today (3/19, Smith).

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