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

Determine patient preferences by means of conjoint analysis

Jul 29, 2014

The Conjoint Analysis (CA) method is in principle suitable to find out which preferences patients have regarding treatment goals. However, to widely use it in health economic evaluations, some (primarily methodological) issues ...

FDA approves hard-to-abuse narcotic painkiller

Jul 25, 2014

(HealthDay)—A new formulation of a powerful narcotic painkiller that discourages potential abusers from snorting or injecting the drug has been approved by the U.S. Food and Drug Administration.

Race affects opioid selection for cancer pain

Jul 25, 2014

(HealthDay)—Racial disparities exist in the type of opioid prescribed for cancer pain, according to a study published online July 21 in the Journal of Clinical Oncology.

FDA approves tough-to-abuse formulation of oxycodone

Jul 25, 2014

(HealthDay)—Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended release) has been approved by the U.S. Food and Drug Administration as a long-term, around-the-clock treatment for severe ...

User comments