FRAMINGHAM, Mass.--(BUSINESS WIRE)-- New England Compounding Pharmacy, Inc. dba New England Compounding Center (NECC), today announced 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, NECC on October 6 initiated a recall of all products currently in circulation that were compounded at and distributed from its facility in Framingham, Massachusetts. This action was taken in cooperation with an investigation being conducted by the U.S. Food and Drug Administration, the Centers for Disease Control and Prevention and the Massachusetts Board of Registration in Pharmacy.
On Monday October 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 (PF) please 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 October 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 at our Website: 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.
Adverse reactions or quality problems experienced with the use of any product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Online: www.fda.gov/medwatch/report.htm1
- Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm2. Mail to address on the pre-addressed form.
- Fax: 1-800-FDA-0178
O'Neill and Associates
Krista Robinson, 617-646-1066
Source: New England Compounding Pharmacy, Inc.