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.

0 shares

Related Stories

Senate questions pharmacy boards after outbreak

date 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

date 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

date 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

date 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

US aims to cut antibiotic use

date Mar 27, 2015

US President Barack Obama on Friday rolled out plans to cut inappropriate antibiotic use by half, in an effort to tackle drug resistance.

Questions over value of new antibiotics to tackle resistance

date Mar 26, 2015

In the first installment of a new series, Peter Doshi, Assistant Professor at the University of Maryland School of Pharmacy and Associate Editor at The BMJ, asks why authorities are approving drugs with little evidence they d ...

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.