The Food and Drug Administration (FDA) has ordered the recall of all unexpired products made by Ameridose, LLC, a compounding pharmacy based in Westborough, Mass., after an inspection of the facility raised concerns about sterility. The recall comes in the wake of a deadly multistate fungal meningitis outbreak that was traced back to steroid shots made by a different compounding pharmacy.

The investigation is ongoing and there have been no reports of patients with infections with any of Ameridose’s products; however, health inspectors say a recall of the products was ordered out of an abundance of caution. “Use of non-sterile injectable products can represent a serious hazard to health that could lead to life-threatening injuries,” the recall notice states.

Compounding pharmacies use drug ingredients that have been approved by the FDA to custom-mix drugs based on doctors’ orders. The pharmacies are regulated by local agencies and not the FDA. This lack of federal oversight has raised questions about the safety of products made by these specialty pharmacies.

This concern has been heightened in recent weeks after it was discovered that steroid shots made by New England Compounding Center in Massachusetts were contaminated with a fungus. To date, 377 people have developed fungal meningitis or fungal joint infections after receiving the tainted shots. Twenty-eight people have died.

Hospitals, clinics, health care professionals, and other customers with Ameridose products on hand are advised to contact Ameridose to obtain instructions on how to return the products to the pharmacy. At this time, the FDA says there is no need to follow up with patients who have received the products.

Any side effects with these or any products should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.

Source: FDA

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