US warns of mold in recalled specialty drugs

by Matthew Perrone

The U.S. Food and Drug Administration warned doctors and hospital managers Monday about a nationwide recall of all drugs made by a New Jersey compounding pharmacy because of possible mold contamination.

The recalled products from Med Prep Consulting Inc. 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 and distributed to regional hospitals in New Jersey, Pennsylvania, Connecticut and Delaware.

Tinton Falls, New Jersey-based Med Prep said Saturday that mold was found in five bags of magnesium sulfate dispensed to a Connecticut hospital. is used to control seizures and premature labor in pregnant women.

Med Prep is a compounding pharmacy, which means it mixes custom formulations of drugs to meet doctors' specifications. The recall marks the second time in less than a year that a compounding pharmacy has recalled all of its products because of contamination.

A tainted steroid distributed last year by a Massachusetts-based compounding pharmacy killed 50 people and has sickened more than 720 nationwide. Many of the cases involved a rare form of meningitis tied to fungus found in the New England Compounding Center's facilities. The company has been shut down since the outbreak was discovered in September.

In recent weeks the FDA has stepped up inspections of compounding pharmacies across a dozen states.

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

The New Jersey State Board of Pharmacy reached an agreement with the company on Friday to shut down all production and shipping of medications.

Med Prep produces liquid formulations that given to patients intravenously.

not rated yet
add to favorites email to friend print save as pdf

Related Stories

Senate questions pharmacy boards after outbreak

Nov 19, 2012

(AP)—A Senate committee investigating a deadly outbreak of meningitis wants to know how regulators in all 50 states oversee specialty pharmacies like the one that triggered the illness.

US clinics rush to warn of tainted steroid; 5 dead

Oct 05, 2012

(AP)—Health providers scrambled to notify patients in nearly two dozen U.S. states that the steroid injections they received for back pain may have been contaminated with a deadly fungal meningitis. Five ...

Congress investigating compounding trade group

Dec 07, 2012

(AP)—House lawmakers are investigating whether the industry group for compounding pharmacies coached the company responsible for a deadly outbreak of meningitis in dealing with regulators.

Consumer watchdog asks FDA to revisit compounders

Nov 29, 2012

(AP)—A government watchdog group is calling on the Food and Drug Administration to re-inspect more than a dozen specialty pharmacies with prior records of violations, in light of a recent deadly outbreak tied to compounded ...

Recommended for you

Novartis Japan admits concealing drug side effects

12 hours ago

The Japanese unit of Swiss pharma giant Novartis has admitted it did not report more than 2,500 cases of serious side effects in patients using its leukaemia and other cancer drugs, reportedly including some fatalities.

Most US babies get their vaccines, CDC says

Aug 28, 2014

(HealthDay)—The vast majority of American babies are getting the vaccines they need to protect them from serious illnesses, federal health officials said Thursday.

Expression of privilege in vaccine refusal

Aug 27, 2014

Not all students returning to school this month will be up to date on their vaccinations. A new study conducted by Jennifer Reich, a researcher at the University of Colorado Denver, shows that the reasons why children may ...

User comments