Oct. 31, 2012 -- Ameridose, a Massachusetts compounding pharmacy closely linked to the NECC pharmacy at the heart of the fungal meningitis outbreak, today recalled thousands of drugs sold to hospitals across the U.S.
There have been no reports of fungal meningitis or other infections in patients who received Ameridose products. An FDA inspection of Ameridose has yet to turn up evidence of contaminated drugs.
But the company today said the "FDA has notified Ameridose that it will be seeking improvements in Ameridose's sterility process. Ameridose and the FDA agree that the use of injectable products that are not sterile can represent a serious hazard to health and could lead to life-threatening illness and/or death."
Ameridose sold more than 2,200 sterile mixed IV solutions and prefilled oral syringes. It offered products ranging from delivery-room medications to neonatal and pediatric drugs to pain pumps for cancer patients. Product lines range from antibiotics to anesthetics to tranquilizers.
The FDA says Ameridose will post a list of all recalled medications on its web site. Customers with Ameridose products should contact Ameridose at 888-820-0622 for instructions on how to return products to Ameridose.
The FDA says it recommended the recall "out of an abundance of caution" after its ongoing inspection "raised concerns about a lack of sterility assurance" for Ameridose products.
Despite the recall, the FDA is not asking doctors, clinics, and hospitals that used Ameridose products to warn patients that received the medications. It's simply asking Ameridose customers to stop using the drugs and to return them to the company.
Some 14,000 patients who received NECC drugs have been warned they might have received fungus-tainted injections.
Today's Ameridose recall will worsen the ongoing shortage of several medicines, the FDA warns.
"The agency is taking all steps within its authority to help prevent or alleviate shortage situations and to minimize the impact this recall may have on drug supplies," FDA Commissioner Margaret Hamburg, MD, said.
Ameridose has the same ownership and management as the New England Compounding Center (NECC). The FDA has found unclean conditions at the NECC, including apparent fungal contamination in sealed vials of injectable drugs.
The death toll and case count in the fungal meningitis outbreak continues to rise. As of today, there have been 29 deaths, 368 cases of fungal meningitis, and nine peripheral joint infections reported from 19 states.