The Delaware Division of Public Health is issuing this health alert in response to a MedWatch Alert issued by the Food and Drug Administration (FDA) regarding the recall of unexpired Ameridose products currently in circulation.
The FDA is currently conducting an inspection of the Ameridose facility as part of the agency’s ongoing fungal meningitis outbreak investigation. Ameridose is a company sharing common management by the same parties as New England Compounding Center (NECC) of Framingham, Massachusetts, the firm associated with compounded drugs linked to the ongoing fungal meningitis outbreak.
The FDA announced today that Ameridose, LLC, is voluntarily recalling all of its unexpired products in circulation. The FDA is currently conducting an inspection of Ameridose’s facility. Preliminary findings have raised concerns about a lack of sterility assurance for products produced at and distributed by this facility.
This recall is not based on reports of patients with infections associated with any of Ameridose’s products.
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