Massachusetts General Hospital

Latest information on Ameridose product recall

31/Oct/2012

We received word today that the pharmaceutical manufacturing company Ameridose is voluntarily recalling its products because of concerns the Food and Drug Administration (FDA) has raised about the company’s sterility-testing methods. We understand that this recall may prompt questions among those who have received Ameridose products. The company earlier today posted a statement saying that, "Ameridose has not received any adverse reports related to the products subject to this recall and neither Ameridose nor the FDA has identified impurities in any Ameridose products." This recall is being conducted out of an abundance of caution.

The MGH is in the process of complying with this recall by taking patients off Ameridose drugs and removing the company’s products from our shelves. Our highest priority is the safety and well-being of our patients, and we are making sure that any patient who has been receiving Ameridose drugs has a safe and effective replacement.

As we have said in previous messages, MGH has purchased medications from Ameridose in the past, but since the company suspended operations several weeks ago, the MGH Pharmacy has reduced its reliance on Ameridose by greatly increasing our in-house compounding processes and finding alternative suppliers of medications. Still, this most recent voluntary recall further exacerbates what is already a complicated and difficult shortage of medications. Our focus continues to be on doing everything we possibly can to ensure safe and uninterrupted access to vital medications for our patients.

Meg Clapp, RPh
Chief Pharmacy Officer

Liz Mort, MD
Interim Senior Vice President, Quality and Safety