Food Recalls (FDA)

Alert – New England Compounding Center Product Recall Information

Published on Friday, 05 October 2012 22:43

FG_AUTHORS: FDA

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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 RELEASEOn 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:

MedicationStrengthPreserved (P) /
Preservative Free (PF)
Lot Number
Methylprednisolone
Acetate
40 mg/mlPF05012012@74
06082012@63
07052012@34
08132012@38
08312012@5
Methylprednisolone
Acetate
40 mg/mlP04242012@91
06272012@7
08082012@103
Methylprednisolone
Acetate
80 mg/mlPF04162012@108
05012012@74
06082012@63
07052012@34
08132012@38
Methylprednisolone
Acetate
80 mg/mlP04062012@44
05222012@13
07302012@72

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:

Methylprednisolone
Acetate
80 mg/mlPF05212012@68
06292012@26
08102012@51

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:

Medication

 

StrengthPreserved (P) / Preservative Free (PF)Lot
Numbers
Betamethasone repository6 mg/mlPFALL
LOTS
Betamethasone repository6 mg/mlPALL
LOTS
Betamethasone sodium
phosphate
6 mg/mlPFALL
LOTS
Betamethasone sodium
phosphate
6 mg/mlPALL
LOTS
Betamethasone sodium
phosphate
8 mg/mlPFALL
LOTS
Betamethasone sodium
phosphate
12 mg/mlPFALL
LOTS
Bupivicaine0.25%PFALL
LOTS
Bupivicaine0.5%PFALL
LOTS
Bupivicaine0.75%PFALL
LOTS
Clonidine100 mcg/mlPFALL
LOTS
Dexamethasone sodium
phosphate
4 mg/mlPFALL
LOTS
Dexamethasone sodium
phosphate
6 mg/mlPFALL
LOTS
Dexamethasone sodium
phosphate
8 mg/mlPFALL
LOTS
Dexamethasone sodium
phosphate
10 mg/mlPFALL
LOTS
Glycerin100%PFALL
LOTS
Hyaluronidase150 u/mlPFALL LOTS
Isovue200 mg/mlPFALL LOTS
Isovue300 mg/mlPFALL
LOTS
Isovue300 mg/mlPFALL
LOTS
Lidocaine/Dextrose5%/7.5%PFALL
LOTS
Lidocaine1%PFALL
LOTS
Lidocaine2%PFALL
LOTS
Lidocaine4%PFALL
LOTS
Omnipaque240 mg/mlPFALL
LOTS
Omnipaque300 mg/mlPFALL
LOTS
Saline10%PFALL
LOTS
Saline3%PFALL
LOTS
Triamcinolone10 mg/mlPALL
LOTS
Triamcinolone40 mg/mlPFALL
LOTS
Triamcinolone40 mg/mlPALL
LOTS
Triamcinolone80 mg/mlPFALL
LOTS

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

###

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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