New England Compounding Pharmacy, Inc. (doing business as New England Compounding Center -- NECC) announces that it has established a Recall Operations Center to process and manage the removal of all NECC products from circulation.
As a precautionary measure, due to the potential risk of contamination, on Oct. 6, 2012 NECC initiated a recall of all products currently in circulation that were compounded at and distributed from its facility in Framingham, Mass. This action was taken in cooperation with an investigation of a fungal meningitis outbreak being conducted by the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC) and the Massachusetts Board of Registration in Pharmacy.
On Oct. 8, NECC established an internal Recall Team responsible for completing all phases of the Oct. 6 recall, as well as prior recalls which commenced Sept. 26. NECC has been working closely with the FDA, the CDC and the Massachusetts Board of Registration in Pharmacy to determine the source of infection in patients who have received injections of methylprednisolone acetate.
For the foreseeable future, NECC staff and professionals will be singularly focused on providing full cooperation with relevant public agencies and on carrying out this recall professionally and expeditiously.
For additional information and a full list of current states and facilities which received lots of methylprednisolone acetate, visit the CDC website at: http://www.cdc.gov/HAI/outbreaks/meningitis.html
While there is no indication at this time of any contamination in other NECC products, the comprehensive recall announced Oct. 6 is being executed out of an abundance of caution.
Products from NECC can be identified by markings that indicate New England Compounding Center by name or by its acronym (NECC), and/or the company logo that appears on www.neccrx.com. A complete list of all products subject to this recall can be accessed at the website.
Clinics, hospitals and healthcare providers that have product which has been recalled should stop using the product immediately, retain and secure the product, and follow instructions provided by NECC with the official recall notice.
For an update on the fungal meningitis outbreak investigation, CLICK HERE.
For a statement from NECC, CLICK HERE.