FDA is seeking improvements in sterility testing process at Westborough, Massachusetts firm
Supplies of some drugs supplied by Ameridose, a US pharmaceutical company, could be further affected by a voluntary recall of all of the company’s products.
Ameridose is voluntarily recalling all of its unexpired products in circulation as part of its cooperation with the US Food and Drug Administration and the Massachusetts Board of Registration in Pharmacy.
The FDA is currently conducting an inspection of the firm’s facility in Westborough, Massachusetts as part of its ongoing investigation into a fungal meningitis outbreak and is seeking improvements in Ameridose’s sterility testing process.
Ameridose shares the same management as the New England Compounding Center (NECC) of Framingham, Mass, the firm associated with compounded drugs linked to the fungal meningitis outbreak, which has so far killed 25 and possibly infected people across 17 US states.
Preliminary findings have raised concerns about a lack of sterility assurance for products produced at this facility
Although the inspection is ongoing, the FDA said its preliminary findings have ‘raised concerns about a lack of sterility assurance for products produced at and distributed by this facility’.
‘Use of non-sterile injectable products can represent a serious hazard to health that could lead to life-threatening injuries,’ the FDA said. ‘Most products produced at and distributed by this facility are represented by Ameridose to be sterile products.’
Ameridose entered into a voluntary agreement with the Massachusetts Board of Registration in Pharmacy to cease all pharmacy and manufacturing operations on 10 October.
The FDA has recommended the recall out of an abundance of caution
Ameridose said the recall is not based on reports of any adverse reactions associated with its products. The FDA said it had recommended the recall ‘out of an abundance of caution’.
‘The FDA’s top priority is to ensure that drugs are safe for the American public,’ said FDA Commissioner Margaret Hamburg.
‘Because the preliminary results of the FDA’s inspection raise concerns about the sterility assurance of Ameridose’s products, the FDA is advising healthcare professionals to stop using all Ameridose products and follow the recall procedures provided by the firm,’ added Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research.
The FDA has identified some Ameridose products that currently appear on the critical shortage list. These products were in shortage before the Ameridose recall, but supplies may be further affected as a result of the Ameridose recall. The FDA is working with alternative manufacturers to maintain supplies of these drugs.
‘The agency is taking all steps within its authority to help prevent or alleviate shortage situations and to minimise the impact this recall may have on drug supplies,’ Hamburg added.