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?"
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Isn't it about time to look at which Senators and Congressmen, and which lobbying groups worked hard to make sure regulations and supervision was as minimal as possible for compounding pharmacies?
It's a shame that the FDA's authority over compounding pharmacies wasn't renewed by Congress in 2002.
Even though there had already been a fungal meningitis outbreak almost identical to the one in Massachusetts.
Is it just coincidence that the GOP was in charge of the House, Senate and Presidency when they refused to reauthorize the FDA to oversee compounders?
Probably not. It would be very interesting to follow the money in that vote.
Greed rules. You must learn to protect yourself.
We must not issue rules to impede job makers.............sarcasm
Yes, but, but testing cost money and that is job a killer-----so you can take your pick now apparently?
So you can accept American drugs with mold, or Chinese drugs with all kinds of poison contamination, but not Canadian or European manufacture? Wonder who with the FDA and Congress is getting the bribes?
Government regulations are BAD BAD BAD ... just let industries police themselves.
Everything will be juuussssttttt fine and dandy.
This is all the result of Big Government over-regulating these patriotic job creators. If they weren't under the burden of all of these costly regulations they would be able to afford utilizing some type of safety protocol. Because of Big Government, these compounding companies have to mix drugs in old mop buckets. If Obama didn't hate America so much, they'd be able to afford to do business. Right now they're just trying to not get crushed by government overreach. It's no wonder they have to cut so many corners and risk the health and lives of non-suspecting patients. If only the socialist, Muslim, Nazi, athiest, mob boss community organizer could stop campaigning and hole himself up out of the sight and minds of Americans, he could spend more time learning how to be an American and stop putting mold in these medications.
Not sure if satire...
or really just that disconnected from reality.
Uhhhmmm, what?
If that is not sarcasm you nee help bran candy
Sarcasm. Gotta be. Right? Please?
FDA is looking the other way...Someone hand got greased...
A hand was greased, but not the FDA's.
The FDA isn't looking away by choice. They are currenty FORBIDDEN to look over the shoulder of these compounding factories.
Congress revoked the FDA's oversight years ago, remember?
We shoul start to dispense justice like the "third world countries" Take a coupl of thes people who endanger othes lives with rotten food and other consumer products out an hang them. Maybe then e can rest when we open a package or go to the doctor..
This company needs to be shuttered permanently.The U.S. government should stop allowing companies to put our lives at risk because they are trying to save a buck.
Actually there's no current evidence that says that Med Prep caused the mold. Until an investigation is completed it could have happened in shipping or storage at the facility. Mold has a way of getting in if everyone in the chain doesn't do exactly what is required from shipping, storage, manufacturing, and dispensing.
The owners and workers need to be sent to prison for life, and if any Sicilian crime families are involved, then they should be executed for the betterment and enlightenment of others, really . . .
Really! :-o
Why does any hospital need to buy 2 Gm of magnesium sulfate added to 50 ml of 5% dextrose in water? Hire a hospital pharmacist to do this or an IV nurse? Make the product up FRESH and use it immediately.
Because of the daily volume they require, it would be impractical to make it all on-site. They'd have to devote an entire wing of the hospital, plus equipment and staff working 24/7, just to manufacture the compounds they use on a daily basis.
It is not exactly rocket science to take a sterile vial and a sterile syringe and add 4 ml of 50% Magnesium Sulfate to a 50 ml IVPB bag of 5% Dextrose. The 700 bed hospital I used to work at in Detroit years ago had 24 hour per day pharmacy service. We made some complicated things but our nurses could add mag sulfate to a IVPB.