N.J. compounding pharmacy recalls drugs nationwide over contamination concerns

WASHINGTONThe Food and Drug Administration is warning doctors and hospital managers about a countrywide recall of all drugs made by a New Jersey compounding pharmacy because they may be contaminated with mold.

The recalled products from Med Prep Consulting Inc. include dozens of drugs packaged in infusion bags, plastic syringes and glass vials distributed to regional hospitals in New Jersey, Pennsylvania, Connecticut and Delaware. More than 70 products are included in the nationwide recall, and they can be found on the FDA's website.

• Compounding pharmacy trouble extends beyond NECC
• 60 Minutes: Lethal medicine linked to meningitis outbreak
• NECC insider describes fraud at heart of meningitis outbreak

The firm's products include antibiotics, general and local anesthetics, cardiac medication, painkillers and drugs for labor and delivery.

The Tinton Falls, N.J.-based company said Saturday that mold was found in five bags of magnesium sulfate products dispensed to a Connecticut hospital. The FDA later identified the particles as fungal. Magnesium sulfate is used to control seizures and premature labor in pregnant women.

No infections have been reported to date, but the FDA says it is working with officials in New Jersey and Connecticut to determine the scope of contamination.

All facilities that have received products from this company have been notified, the FDA said. The N.J. firm has agreed to temporarily halt all productions.

"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 an emailed statement.

Med Prep is a compounding pharmacy, which means it mixes custom formulations of drugs to meet doctors' specifications.

A tainted steroidal painkiller distributed by an unrelated compounding pharmacy last year, the New England Compounding Center of Framingham, Mass., has killed 50 people and sickened more than 720 nationwide. Many patients had developed a rare type of fungal meningitis, and other secondary infectionssuch as abscesses at  injection sites.

Last Oct., an FDA investigation at that facility found mold and fungus in drug vials and cleaning equipment.

60 Minutes recently profiled the outbreak tied to the New England Compounding Center.