Health Alert
RECALL OF UNEXPIRED AMERIDOSE PRODUCTS

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.

Background

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.

Recommendations

1. Health care professionals should stop using Ameridose products at this time. Products from Ameridose can be identified by markings that indicate Ameridose by name or by its company logo. To see the company logo or a complete list of all products subject to this recall visit www.ameridose.com.
2. Hospitals, clinics, health care professionals, and other customers with Ameridose products should contact Ameridose at 888-820-0622 to obtain instructions on how to return products to Ameridose.
3. At this time, health care professionals do not need to follow up with patients who received Ameridose products.

Additional Information

• FDA MedWatch new release: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm326370.htm
• Health care professionals and patients may dial the FDA’s Drug Information Line at 855-543-DRUG (3784) and press * to get the most recent information regarding the Ameridose recall and speak directly to a pharmacist.
• Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products online at www.fda.gov/MedWatch/report.htm
• Delaware Division of Public Health, Bureau of Epidemiology (24/7): 1-888-295-5156.

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