Recall -- State / Local Press Release

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ATTENTION ALL LICENSED HEALTH CARE FACILITIES AND PHYSICIANS IN MASSACHUSETTS

Alert – New England Compounding Center Product Recall Information

Contact
The Commonwealth of Massachusetts
Executive Office of Health and Human Services
Department of Public Health
250 Washington Street
Boston, MA 02111
617-624-5000

New England Compounding Center at 508-820-1616

FOR IMMEDIATE RELEASE – On October 4, 2012, out of an abundance of caution, the CDC and FDA recommended that all health care professionals cease use and remove from their pharmaceutical inventory any product produced by the New England Compounding Center (NECC), located at 697 Waverly Street in Framingham, MA.

The Massachusetts Department of Public Health (DPH) is collaborating with the U.S. Centers for Disease Control
and Prevention (CDC) and the Food and Drug Administration (FDA) on a multi-state investigation of Aspergillus
meningitis among patients who received an epidural steroid injection. As of October 4, 2012, 35 cases have been
reported to CDC, including 5 deaths. The three principally implicated lots have not been distributed in Massachusetts. According to CDC, fungal meningitis, which is not transmitted from persons to person, from a potentially contaminated drug product is suspected to be the cause of the outbreak. At this time, no cases have been reported in Massachusetts.

Specific information on these recalled lots as well as critical information from the CDC is attached to this communication.

Additionally, the CDC is updating information for clinicians daily at 2 pm at the following webpage:
http://www.cdc.gov/hai/outbreaks/meningitis.html

With questions regarding case definitions of Aspergillus meningitis, please contact the DPH Epidemiology Hotline - 617-983-6800.

New England Compounding Center
697 Waverly Street
Framingham, MA 01702

URGENT
VOLUNTARY PRODUCT RECALL

October 3, 2012

Dear Customer,
The following medications are subject to this voluntary recall:

The above referenced products are being voluntarily recalled.  The voluntary recall has been initiated due to the potential for foreign particulate matter within the vial.
These above lots are in addition to the following three lots previously recalled:

If you have any of the above lot(s) on hand, immediately segregate and quarantine the material.  Please annotate on the attached form the
current status of these lot(s) in your facility and fax the form to New England Compounding Center at 508-820-1616.  Once the form has been returned to New England Compounding Center, we will contact you to arrange for return of all materials.
We thank you for your cooperation, and apologize for any inconvenience.  If you have further questions regarding this recall, please contact our Pharmacy Department at 800-994-6322.
Sincerely,
New England Compounding Center

Dear Customer,
The following medications are subject to this voluntary recall:

If you have any of the above lot(s) on hand, immediately segregate and quarantine the material.  Please annotate on the attached form the current status of these lot(s) in your facility and fax the form to New England Compounding Center at 508-820-1616.  Once the form has been returned to New England Compounding Center, we will contact you to arrange for return of all materials.
We thank you for your cooperation, and apologize for any inconvenience.  If you have further questions regarding this recall, please contact our Pharmacy Department at 800-994-6322.
Sincerely,
New England Compounding Center

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For a list of Recalled Products and additional information related to the Fungal Meningitis Outbreak, refer to the full FDA Statement in our Drug Safety and Availability section. 

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