Mold risk leads to recall of products from NJ compounding pharmacy
Written by Jay M. Kelley III in Drug & Medical Devices on March 22, 2013
Compounding pharmacies are making news again. In October, three lots of injected steroids produced by The New England Compounding Center were recalled after the compounds were linked to a deadly meningitis outbreak.
Now, the New Jersey Health Department is advising hospitals, health care providers and pharmacists to immediately stop using all products produced by Med Prep Consulting Inc.
The New Jersey compounding pharmacy issued a nationwide recall of all its products because visible particulate contaminants were seen in intravenous solution received by a Connecticut hospital. Five contaminated bags of magnesium sulfate were discovered at the facility. This prompted the U.S. Food and Drug Administration to recall all magnesium sulfate compounded by Med Prep. The recall was later expanded to all products made by the compounding pharmacy.
Administration of an intravenous product contaminated with mold could cause a fatal infection. To date, no injuries or illnesses have been reported.
The products are used for a wide range of therapeutic uses for hospitalized inpatients and outpatients, and, patients directly treated by a health care professional at a physician’s office practice facility or clinic. None of these products are dispensed directly to patients from retail pharmacies or to home care patients for either self-administration or nursing administration. All products are packaged in plastic infusion bags, plastic infusion devices, plastic syringes and glass vials.
A list of Med Prep products included in the recall is available on the FDA website.
After the meningitis outbreak last year, there was a cry for tighter restrictions and more oversight of these compounding pharmacies. These pharmacies are not as closely regulated as major pharmaceutical companies like Pfizer or Bayer. This latest incident likely will be another motivation for the FDA and other government agencies to crackdown on these facilities.
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