March 18, 2013 at 12:31 PM ET
A New Jersey compounding pharmacy has temporarily shuttered operations after Connecticut hospital officials reported finding visible mold in bags of a vital injection drug.
Med Prep Consulting Inc., of Tinton Falls, agreed to stop making and shipping medications after recalling all lots of all products -- including the magnesium sulfate intravenous solution that sparked concerns starting last week, Food and Drug Administration officials said Monday.
The move followed a voluntary consent order enacted Friday that will remain in effect until at least March 22, officials with the New Jersey State Board of Pharmacy said. The recall potentially affects thousands of bags, syringes and vials of premixed solution.
“This investigation is evolving. At this time, in an abundance of caution, the Department of Health recommends that any health care facility that has received products from Med Prep should inventory them and remove them from use,” New Jersey Health Commissioner Mary E. O'Dowd said in a statement.
At least thirteen 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 Connecticut officials last week identified "visible floating particles" in the potentially contaminated drugs, New Jersey pharmacy board officials said.
Mold was confirmed in five bags of the drugs after the Connecticut hospital raised questions, the FDA said. There have been no reports of illness in any patients who received the drugs, which was distributed between Feb. 18 and March 13 to regional hospitals.
Investigators from the state pharmacy board and the FDA were at the pharmacy site over the weekend, said Angelo J. Cifaldi, a lawyer representing Med Prep.
The affected drugs include 88 orders that could range from as few as 10 to 20 bags of magnesium sulfate solution per order to 500 bags per order, Cifaldi said. He added that it is not clear how many patients may have received the drugs.
"That doesn't mean it all went to the patients," he said. "It could be sitting on the hospital shelves."
The action comes six months after a deadly outbreak of fungal meningitis tied to contaminated injection steroids manufactured by a Massachusetts compounding pharmacy, the New England Compounding Center. Fifty people have died among 722 sickened by contaminated epidural painkillers, the Centers for Disease Control and Prevention said.
The NECC incident prompted Congress and others to call for an overhaul of oversight of compounding pharmacies in the U.S.
FDA officials warned Med Prep Consulting president Gerald R. Tighe in 2001 and in 2010 about problems with sterility in certain repackaged drugs, agency records show.
FDA and CDC officials are investigating the recall and any potential patient harm. All facilities that received Med Prep compounded products have been notified to remove and return the products to the pharmacy. The firm's products include antibiotics, local and general anesthetics, cardiac, labor and delivery and pain medications.
The New Jersey board of pharmacy noted that the consent order is not a disciplinary action and does not represent an admission of wrongdoing on the part of the company.
"We don't know where the contamination occurred," said Cifaldi, noting that the company used ingredients from several large manufacturers. "I'm not pointing fingers, but who knows if something happened at the hospital?"