The Federal Drug Administration has released a list of customers, who received products from New England Compounding Center in Framingham on or after May 21. The list does not identify what products the customers received.
The fungus has been linked to a deadly meningitis outbreak that has infected more than 300 in 17 states and killed 23 individuals. NECC has maintained the steroids were not distributed in Framingham or Massachusetts.
Over Columbus Day weekend, NECC recalled all of its 1,200 products. For a list, click here. This new list by the FDA indicates which health care facilities and hospitals received any NECC products since May.
The FDA list includes customer names and addresses and is organized by state. (Click on the word list to see the FDA list.)
The lists were prepared based on information provided by NECC, said the FDA and it cannot vouch for the accuracy of the list. Products shipped by NECC may be missing from the list and facility information may be incomplete, said the FDA.
The FDA released a list earlier this week, but quickly recalled it when they realized it may not be accurate.
"The current list is the best information we have available, at this time, to help inform facilities and healthcare providers of NECC products shipped to their facilities since May 21, 2012," said the FDA.
Earlier this week, Massachusetts revoked the compounding pharmacy's license.
And Congressman Ed Markey, who is the senior official with oversight of the FDA, said he believes NECC fell into a "black hole" when it came to regulations. NECC was regulated by the federal and the state governments. Framingham Board of Health had no oversight whatsoever, said Health Board Chair Michael Hugo.
Markey said he believed one of the reasons for this outbreak is that NECC was doing work outside its license and was acting as a compounding manufacturer and not a compounding pharmacy and he is submitting legislation to so the government has more oversight over these facilities.
FDA is reiterating and updating its previous recommendation that follow-up with patients be done when the following three conditions are met:
- The medication was an injectable product purchased from or produced by NECC, including an ophthalmic drug that is injectable or used in conjunction with eye surgery, or a cardioplegic solution.
- The medication was shipped by NECC on or after May 21, 2012.
- The medication was administered to patients on or after May 21, 2012.
Below are more recommendations from the FDA:
Advice to NECC Customers: Customers identified on these lists should check their stocks to identify whether they have any products from the New England Compounding Center (NECC), and they should immediately isolate any identified product from their drug supplies. All NECC products are subject to voluntary recall. Customers with product on hand should contact NECC at 1-800-994-6322 or via fax at 508-820-1616 to obtain instructions on how to return products to NECC.
Advice to Patients: Patients who believe they received an injection or other product that was shipped by NECC on or after May 21, 2012 should remain vigilant for the signs and symptoms of infection, and contact their health care provider if they are concerned. The meningitis outbreak has occurred in patients who received injections near the spine (back or neck). The signs and symptoms of meningitis include fever, headache, stiff neck, nausea and vomiting, photophobia (sensitivity to light) and altered mental status. Symptoms for infections following other types of injections at other body sites may vary, and are not limited to meningitis. Other possible infections at other parts of the body (e.g., peripheral joints) may include fever; swelling, increasing pain, redness, warmth at an injection site; visual changes, pain, redness or discharge from the eye; chest pain, or drainage from the surgical site (infection within the chest). Patients should contact their healthcare provider if they have any of these signs or symptoms.
Patients who received an NECC product prior to May 21, 2012 and who have not experienced symptoms of infection to date are at less risk of infection because of the amount of time that has elapsed since that date. FDA is not recommending these patients follow-up with their health care providers unless they are experiencing symptoms of infection.