Mold Contaminated Medication Prompts FDA Recall

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Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Pharma Industry / Biotech Industry
Article Date: 20 Mar 2013 - 11:00 PDT


The U.S. Food and Drug Administration cautioned doctors and hospital staff on Monday about a nationwide recall of all medications made by a New Jersey compounding pharmacy because of a potential mold contamination.

The recalled medications from Med Prep Consulting Inc. included many pain relievers, antibiotics, and drugs used in labor and surgery. The medications were put in infusion bags, glass vials, and plastic syringes and given out in regional hospitals in Pennsylvania, Delaware, and New Jersey.

Mold was found in five bags of magnesium sulfate given to a Connecticut hospital. Magnesium sulfate is used to regulate premature labor in women as well as seizures.

Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research explained:

"Giving a patient a contaminated injectable drug could result in a life-threatening infection. 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."

The FDA says the investigation continues and they will work with the CDC and state officials in Connecticut and New Jersey to measure the range of contamination. This level of recall is a "user level" one - consisting of regional hospital pharmacies and associated departments, and physician's departments.

The FDA added that Med Prep Consulting Inc. has temporarily halted all production - including processing and shipping medications.

Med Prep Consulting Inc. makes a number of sterile products for intravenous administration for many different medical issues. The company's products include:

• general and local anesthetics
• antibitoics
• pain management medications
• cardiac, labor, and delivery medications

Last year, a contaminated steroid given out by a Massachusetts-based pharmacy caused 50 deaths and infected more than 720 patients throughout the United States. Several of the cases were of a rare form of meningitis tied to fungus found in that center's facilities. The company has been closed since the outbreak that happened in September.

Currently, the FDA has tightened inspections of compounding pharmacies among a dozen states.

As of today, there have not been any reports of injury or illness linked to the recalled magnesium sulfate solutions however, the FDA is asking consumers and healthcare professionals to report any negative reactions to the FDA's MedWatch Program.

Written by Kelly Fitzgerald
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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