Mold – Another Compounding Pharmacy Recall
March 18th, 2013 // 2:56 pm @ jmpickett
Avoid Warning Letter Disasters With a Strong Quality Agreement
In the latest fallout from the compounding pharmacy scandal, a compounder has recalled all of its nearly 100 products after a Connecticut hospital noticed “visible particulate contaminants†that turned out to be mold in 50 millimeter bags of an intravenous solution. The move was disclosed on the FDA web site this morning.
An attorney for Med Prep Consulting, which is based in Tinton Falls, New Jersey, tells us there were no reported advere events or injuries associated with the contamination, but the recall is being conducted “out of an abundance of caution and after consulting with the FDA.†We asked the FDA for comment and will update you accordingly.
The recall follows a sensational scandal in which 722 cases of fungal meningitis, including 50 deaths (see this) were traced to the New England Compounding Center. The outbreak has been described as one of the worst public health crisis in the US in decades and placed enormous pressure on the FDA and state health agencies to step up compounder oversight.
The FDA, in fact, recently began a new crackdown on compounding pharmacies that is targeting about 30 so-called ‘high risk’ operations in nearly a dozen states (read here). So far, the agency has issued inspection reports for 15 compounders, although Med Prep is not listed among them (look here).
The agency move came after a Congressional hearing in which FDA officials were criticized for not moving faster to prevent NECC from shipping medicines in large quantities across state lines. The FDA, however, continues to maintain that additional Congressional authority is needed to more effectively
Avoid Warning Letter Disasters With a Strong Quality Agreement
As for Med Prep, its products are used to treat various maladies in hospitalized inpatients and outpatients, as well as patients treated directly by physicians. None of its products are dispensed directly to patients from retail pharmacies or to homecare patients for either self-administration or nursing administration. Some products were distributed to hospital pharmacies in New Jersey, Pennsylvania, Connecticut and Delaware, while others were distributed nationally to physician offices and clinics.
