Contamination found in more NECC products. (New England Compounding Center)

[nc4bo]

http://www.gainesville.com/article/20121102/WIRE/121109912/1109/sports?Title=Contamination-found-in-more-NECC-products

The Associated Press
Published: Friday, November 2, 2012 at 1:23 p.m.
Last Modified: Friday, November 2, 2012 at 1:23 p.m.

FRAMINGHAM, Mass. — Federal regulators say they have found contamination in more drugs made by a pharmacy tied to a deadly meningitis outbreak.

The U.S. Food and Drug Administration said it doesn't yet know the significance of the bacterial contamination discovered in recalled New England Compounding Center products. Some of the bacteria found are rarely cited as a cause of disease in humans. And no NECC products have been tied to reports of infection from the bacteria, the FDA said.

But the agency said the findings bolster concerns about a lack of sterility at the now-closed company. Investigators there have already found standing water from a leaking boiler, filthy floor mats and records indicating drugs were shipped before sterility tests were returned.

The FDA test results were released hours after an announcement Thursday by U.S. Rep. Ed Markey that he'll introduce legislation to strengthen the federal oversight over compounding pharmacies, which custom-mix solutions that generally aren't commercially available. They aren't regulated by the FDA.

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Not sure if this has been reported yet.

From the CDC (I edit to put in more info. Go to link for more info):

http://www.cdc.gov/hai/outbreaks/currentsituation/

Related Drug Recalls

Recalls of medications beyond the three lots of preservative-free MPA are ongoing.

On October 6, 2012 NECC voluntarily recalled all productsExternal Web Site Icon compounded at and distributed from its facility in Framingham, Massachusetts. The product list Adobe PDF file [PDF - 71 pages]External Web Site Icon, posted on FDA’s website, was the focus of an October 15 MedWatch AlertExternal Web Site Icon. FDA advised clinicians out of an abundance of caution to follow up with patients who were administered NECC injectable products, including an ophthalmic drug that is injectable or used in conjunction with eye surgery and a cardioplegic solution. Investigation and laboratory testing of products is ongoing by CDC and FDA.
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On October 31, 2012 The U.S. Food and Drug Administration announced that Ameridose, LLC, based in Westborough, Mass., voluntarily recalled all of its unexpired products in circulation. Products from Ameridose can be identified by markings that indicate Ameridose by name or by its company logoExternal Web Site Icon. A complete list of all products subject to this recall can be accessed at www.ameridose.comExternal Web Site Icon. Together with the State of Massachusetts, the FDA commenced the current inspection of the Ameridose facility as part of the agency’s ongoing fungal meningitis outbreak investigationExternal Web Site Icon. Ameridose is a company sharing common management by the same parties as New England Compounding Center (NECC) of Framingham, Mass., the firm associated with compounded drugs linked to the ongoing outbreak.
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November 1, 2012 Health Alert Network (HAN): Contamination Identified in Additional Medical Products from New England Compounding Center

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November 1, 2012 Health Alert Network (HAN): Voluntary Recall of All Ameridose Medical Products

More at the CDC link.

[LiberalEsto]

1. I got a cortisone injection in my knee in September

and have had an unusual amount of pain since, starting three days after the shot.

This pain is different from the osteoarthritis pain, and in a different area of the knee. I've never had problems with cortisone (in my lower spine) shots before.

The orthopedist, when I asked him about it, said the cortisone he used on me was "different" from the type used for spinal injections. He could not explain my pain or do anything more about it. I quit physical therapy because it hurt too much. In desperation I had acupuncture, and it helped for nearly a week but came back. I can't afford more acupuncture.

A couple of weeks ago I checked on the CDC web site and saw that the medical group I went to for the knee was NOT listed among the places in Maryland receiving shipments from the contaminated compounding factory in Massachusetts. So I thought that could be ruled out.

But the pain continues. I can barely walk, and it hurts if anything touches the side of my knee. I can't take pain relievers.

I think it's about time for me to call the CDC and ask questions.

[nc4bo]

3. I would. Just to be sure.

I don't think any one actually knows the depth of any of this. Not trying to sound panicky or anything but seems there may be more problems revealed as time goes on and people should be made aware!

I'm sorry LiberalEsto hopefully the problem isn't related.

[BlueToTheBone]

2. Loosening regulations was a Mitt gift

of contaminated drugs to all of us.

[nc4bo]

4. Regulations? I'm going to get rid of all that - Mitt Romney (R)

And it's always the little people that pay the price.