Ameridose Pharmacy Recalls all Products
Ameridose Sterile Admixing Services, a pharmacy that shares owners with New England Compounding Center, has recalled all products in light of an FDA investigation into sterility testing procedures.
New England Compounding Pharmacy has been linked to contaminated methylprednisolone acetate epidural injections that have caused a fungal meningitis outbreak that has left 28 dead and more than 380 injured in the U.S.
“Ameridose and FDA agree that the use of injectible products that are not sterile can represent a serious hazard to health and could lead to life-threatening injuries and/or death,” Ameridose press release.
Ameridose Sterility Procedures Questioned
According to the FDA, during a recent inspection, investigators identified shortcomings in sterility testing procedures at Ameridose’s Westborough, Massachusetts facility. As a result, the company recalled all unexpired products out of “an abundance of caution.”
“Because the preliminary results of the FDA’s inspection raise concerns about the sterility assurance of Ameridose’s products, the FDA is advising health care professionals to stop using all Ameridose products and follow the recall procedures provided by the firm,” Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research.
Ameridose Recall Information
- A complete list of all products subject to this recall can be accessed at www.ameridose.com
- Hospitals, clinics, health care professionals, and other customers with Ameridose products on hand should contact Ameridose at 888-820-0622.
- Health care professionals and patients can obtain up to date info on the recall and/or speak to a pharmacist by calling the FDA’s Drug Information Line at 855-543-DRUG.
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