New England Compounding Center Issues Voluntary Nationwide Recall of All Products Due to Meningitis Outbreak; Closes Manufacturing Center

Tuesday, October 09, 2012

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

At least 105 people in nine states, including Florida, have contracted meningitis. The outbreak is allegedly due to contaminated epidural spinal injections of methylprednisolone linked to New England Compounding Center (NECC) in Framingham, Massachusetts. The manufacturing center is now closed, and the company has issued a voluntary recall of all products distributed since January 2012.

Click here to see the recall announcement from NECC.


Voluntary Recall Due to Investigation By the U.S. Food and Drug Administration (FDA).

On October 6, 2012, NECC announced the recall of all products currently in circulation. This action was taken out of caution and in conjunction with a Food and Drug Administration (FDA) investigation.

To see a list of all NECC recalled products, click here.

The Tennessee DOH notified the Centers for Disease Control and Prevention (CDC) on September 21, 2012, about a case of meningitis that a patient contracted about 19 days after receiving an epidural injection. One week later another case was reported in a different state.

NECC has suspended its operations while the investigation continues.


Meningitis Cases in Florida.

According to the Florida Department of Health (DOH), eight Florida centers have received the contaminated medication. The centers are:

 -  Florida Pain Clinic, Ocala,
 -  Marion Pain Management Center, Ocala,
 -  Orlando Center for Outpatient Surgery, Orlando,
 -  Pain Consultants of West Florida, Pensacola,
 -  Surgery Center of Ocala, Ocala,
 -  Surgical Park Center, Miami,
 -  Interventional Rehab Center, Pensacola, and
 -  North County Surgicenter, Palm Beach.

Currently, the state DOH is investigating four cases of confirmed meningitis in Marion County, Florida.

Click here to see a press release from the state DOH on the outbreak.


Eye Infections from Florida Compounding Pharmacy.

I previously blogged about the problems encountered by Franck’s pharmacy in Ocala, Florida. It has been accused of distributing eye medications that contained a fungal infection. Click here for the first blog and here for the second blog.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in investigations, regulatory matters, licensing issues, litigation, inspections and audits. The firm's attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.
 
To contact The Health Law Firm please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.


Comments?

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Sources:

Jacobson, Susan “Orlando Clinic Injected Patients with Steroid Linked to Meningitis Outbreak.” Orlando Sentinel. (October 5, 2012). From: http://www.orlandosentinel.com/news/local/breakingnews/os-meningitis-outbreak-orlando-20121005,0,4108088.story

Reynolds, Hue. “Florida Department of Health Update: New England Compounding Center Voluntary Product Recall.” Florida Department of Health. (October 7, 2012). From: http://newsroom.doh.state.fl.us/wp-content/uploads/newsroom/2012/10/NECCVoluntaryProductRecall.pdf


About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law.  He is the President and Managing Partner of The Health Law Firm, which has a national practice.  Its main office is in the Orlando, Florida, area.  www.TheHealthLawFirm.com  The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone:  (407) 331-6620.


Tag Words: compounding, pharmacy lawyer, pharmacy attorney, pharmacy, pharmacist, New England Compounding Center (NECC), compounding, product recall, meningitis, meningitis outbreak, Centers for Disease Control and Prevention (CDC), Drug Enforcement Agency (DEA) attorney, U.S. Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), drug recall, pharmacy investigation, defense attorney, defense lawyer, meningitis outbreak Florida

"The Health Law Firm" is a registered fictitious business name of George F. Indest III, P.A. - The Health Law Firm, a Florida professional service corporation, since 1999.
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10/9/2012

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