Framingham-based New England Compounding Pharmacy, Inc. dba New England Compounding Center (NECC), Wednesday announced it has established a Recall Operations Center to process and manage the removal of all 1,200 NECC products from circulation, according to a press release.
As a precautionary measure, due to the potential risk of contamination, 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.
The company has been tied to the national meningits outbreak, which has left 11 dead in 9 states and infected more than 135 individuals with fingal meningitis.
On Monday 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, it stated in a release.
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, said the company in a release.
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 Oct. 6 is being executed out of an abundance of caution, said the company in a statement.
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 here.
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.
• 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