Ameridose LLC, the sister company to the compounding pharmacy linked to a fungal meningitis outbreak that has sickened 377 in 28 states and killed nine people, announced a recall of all of its products yesterday after federal inspectors discovered inadequacies in its sterility testing procedures.
The Westborough, Mass.- based company, which distributes drugs to thousands of hospitals nationwide, notified its customers of the recall in a letter. “During the course of its on-going inspection of our facility, FDA has notified Ameridose that it will be seeking improvements in Ameridose’s sterility testing process. 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,” the letter states.
At this time the company is not aware of any illnesses related to the products under recall and “neither Ameridose nor the FDA has identified impurities in any Ameridose products. Nevertheless, out of an abundance of caution, we are undertaking this recall to assure customers that when Ameridose products are shipped, they are fully in conformance with all of the FDA’s recommendations.”
The fungal meningitis outbreak linked to Framingham, Mass.-based New England Compounding Center, Ameridose’s sister company, has sickened 377 people in 28 states and killed nine, according to the latest update from the Centers for Disease. The CDC and FDA have confirmed the presence of a fungus known as Exserohilum rostratum in unopened medication vials of preservative-free methylprednisolone acetate produced by NECC. That is the same fungus that has been detected in patients who received injections of the drug nationwide.
