A sharp-eyed nurse at Yale-New Haven Hospital in Connecticut is being credited with raising a warning last week about floating mold in vital intravenous drugs, prompting a mass recall -- and possibly averting serious infections in patients in at least four states.

The nurse spotted the debris in a bag of magnesium sulfate IV solution as part of a routine safety check, according to spokesman Rob Hutchison.

“This nurse pulled it and immediately called the pharmacy,” said Hutchison, who didn’t identify the employee.

The hospital quickly quarantined about 40 different types of drugs produced by Med Prep Consulting Inc., a Tinton Falls, N.J., compounding pharmacy that has recalled all lots of all drugs and temporarily ceased operations under a consent order imposed by the state pharmacy board.

Five bags with floating mold were found at Yale-New Haven Hospital; tests showed the debris was a still-unidentified fungus. Eighty-eight orders of the magnesium sulfate solution -- in shipments ranging from 10 to 20 bags up to 500 bags -- were sent to 13 hospitals including Yale-New Haven, according to Angelo J. Cifaldi, a lawyer for Med Prep.

Hospital officials are reaching out to doctors and patients who may have received the contaminated drugs, Hutchison said. Health officials in Connecticut, New Jersey, Pennsylvania and Delaware all said they are working with federal investigators to determine what steps to take next. The drugs were produced and delivered between Feb. 18 and March 13.

The worry is that patients may have been injected with tainted 50-millileter doses of magnesium sulfate 2 gram in dextrose 5 percent solution in water.

“Giving a patient a contaminated injectable drug could result in a life-threatening infection,” Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research for the Food and Drug Administration, said in a statement.

So far, no infections or other problems have been reported, FDA officials said.

But it’s a worrisome -- and very real -- possibility six months after an outbreak of fungal meningitis tied to contaminated pain shots that have been tied to 722 illnesses and 50 deaths.  The now-bankrupt compounding pharmacy blamed in that outbreak, New England Compounding Center of Framingham, Mass., had serious problems with contamination and sterility, investigations showed.

In addition to the magnesium sulfate solution -- which is used to replace electrolytes in hospitalized patients -- Med Prep also makes a wide variety of sterile drugs, including antibiotics, anesthetics, cardiac, labor and delivery and pain management medications, according to the FDA.

The firm received FDA warnings about its sterility practices in 2001 and 2010, agency records showed.

The 1,541-bed Yale-New Haven hospital has used drugs from compounding pharmacies in order to meet the demand for the volume of vital medications, Hutchison said. Drug shortages in recent years -- particularly shortages of sterile injectables -- have sent many hospitals to compounding pharmacies, experts say.

Of the 86 drugs affected by the Med Prep recall, 53 are in short supply, according to Erin Fox, manager of the Drug Information Service at the University of Utah, which tracks drug shortages. 

After pulling the Med Prep products, the hospital is trying to find ways to replace the drugs -- and mixing many of the specialized products themselves.

“We’re working very hard to source products from other vendors,” Hutchison said.

Many of the drugs will be unavailable, however, Fox said. And it can be very hard for a hospital to ramp up its own sterile drug production quickly. 

"I think it's concerning anytime a hospital is completely starting from scratch in a day or two."

Related stories: 

• Visible mold forces recall of N.J. pharmacy injection drugs
• Six months after fungal meningitis outbreak, patients still getting infections

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?"

Related stories:

• Six months after fungal meningitis outbreak, patients still get infections
• Pharmacy tied to fungal meningitis outbreak files for bankruptcy