Meningitis probe extends to NECC sister company
pharmafile | November 1, 2012 | News story | Manufacturing and Production |Â Â NECC, ameridose, meningitisÂ
A second compounding pharmacy has been drawn into the investigation into the meningitis outbreak that has killed 29 people in the US.
Ameridose – part of the same group of companies that includes New England Compounding Centre (NECC) – has issued a voluntary recall of all of its products following an inspection by the FDA which raised concerns about its production processes.
“Although this inspection is ongoing, the FDA’s preliminary findings have raised concerns about a lack of sterility assurance for products produced at and distributed by this facility,” said the agency in a statement.
“Most products produced at and distributed by this facility are represented by Ameridose to be sterile products,” added the FDA, which warned that the recall includes products currently listed on its critical shortage list.
“The agency is taking all steps within its authority to help prevent or alleviate shortage situations and to minimize the impact this recall may have on drug supplies,” said FDA Commissioner Margaret Hamburg.
The recall comes after Ameridose entered into a voluntary agreement with the Massachusetts Board of Registration in Pharmacy to cease all pharmacy and manufacturing operations on 10 October, although both the company and FDA stress there is no suggestion that patients have been harmed by products made at the company’s Westborough facility.
Authorities in the US are paying close attention to the actions of compounding pharmacies in the wake of the NECC incident, in which contamination of supposedly sterile products including injectable steroids with a fungus caused a fatal outbreak of meningitis.
Unlike pharmaceutical manufacturers, compounding pharmacies are not regulated by the FDA, and are instead overseen by state pharmacy boards. Congressional investigators claim that federal and state health regulators knew of potential problems with NECC steroid treatments as long ago as 2002.
Meanwhile, a third compounding pharmacy called Infusion Resource has also been shut down over sterility concerns, according to Reuters, although this one is not affiliated with NECC.
Phil Taylor
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