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  1. #1
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    New England Compounding Center Product Recall Information *** Many Prescriptions

    New England Compounding Pharmacy, Inc. d/b/a New England Compounding Center (NECC) today announced a recall of all products currently in circulation that were compounded at and distributed from its facility in Framingham, Massachusetts. This action is being taken out of an abundance of caution due to the potential risk of contamination, and 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.

    From an email I received from the FDA today, a ton of medicine, including pediatric drugs and cancer patient pain killers to acne treatments and saline. Here is the very long list

    http://www.fda.gov/downloads/Safety/.../UCM322970.pdf

  2. #2
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    I can't get this to load, fhc. May just be my computer, though.
    Thoughts and prayers for the people of Paris and all of France!

  3. #3
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    Wink

    Quote Originally Posted by LaLaw2000 View Post
    I can't get this to load, fhc. May just be my computer, though.
    oh goodness, idk if i can c & p this pdf document...If you have concerns about a particular medication, let me know and I'll check the list.

  4. #4
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    yes! oh my that is a long list... I read thru for about 15 min and only got to the H's ... there are dialysis solutions on this list, dilaudid (a lot of that) lidocaine and other injectables for numbing (no one get a cut that needs sutures!)

    most seemed like they are inject. (solutions).. I will try to write up a "people terms" list tomorrow..

  5. #5
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    Quote Originally Posted by fhc View Post
    oh goodness, idk if i can c & p this pdf document...If you have concerns about a particular medication, let me know and I'll check the list.
    I think that is a good idea (if people have a med concern we can check the list) great idea fhc!

  6. #6
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    Thanks, fhc! I wanted to see the list to make sure I do not have any of the ones listed. I went to the fda.gov site and did not see it.

    But no worries, I will find it somewhere!
    Thoughts and prayers for the people of Paris and all of France!

  7. #7
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    Quote Originally Posted by nursebeeme View Post
    yes! oh my that is a long list... I read thru for about 15 min and only got to the H's ... there are dialysis solutions on this list, dilaudid (a lot of that) lidocaine and other injectables for numbing (no one get a cut that needs sutures!)

    most seemed like they are inject. (solutions).. I will try to write up a "people terms" list tomorrow..
    Thanks, nursebeeme!
    Thoughts and prayers for the people of Paris and all of France!

  8. #8
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    Quote Originally Posted by LaLaw2000 View Post
    I can't get this to load, fhc. May just be my computer, though.
    Quote Originally Posted by LaLaw2000 View Post
    Thanks, fhc! I wanted to see the list to make sure I do not have any of the ones listed. I went to the fda.gov site and did not see it.

    But no worries, I will find it somewhere!
    Try it this way, go to this link

    http://www.fda.gov/Safety/Recalls/uc...ce=govdelivery

    then click on the link

    A complete list of all products subject to this recall can be accessed here.

  9. #9
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    Thanks so much, fhc! That works. I appreciate it very much.
    Thoughts and prayers for the people of Paris and all of France!

  10. #10
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    The pdf. document had 71 pages * appx. 25 per page = 1775 products. Incredible huh?


  11. #11
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    It looks like to me that it affects the soluble (liquid) medications, which are many. Perhaps only solid pills are not affected.
    Just horrible.....
    - - - - - - - - - - - - - - - -
    "Look, if any of us wanted to mind our own business, we wouldn't be here" (carbuff 8/11/13)

    This post reflects my constitutionally-protected opinion. Please do not copy it anywhere else outside of the WebSleuth forum

  12. #12
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    Criminal investigators visit Massachusetts drug facility


    http://www.cnn.com/2012/10/16/health...eak/index.html

    (CNN) -- Criminal investigators from the Department of Justice and the Food and Drug Administration were at a Massachusetts pharmaceutical company on Tuesday with a search warrant, a company spokesman said.

    Federal officials say that more issues have been reported with drugs from the New England Compounding Center, or NECC, which has been linked to a deadly multistate outbreak of fungal meningitis.

    FDA spokeswoman Erica Jefferson confirmed that criminal investigators were on site, but declined to answer questions regarding a warrant.

    U.S. Attorney Carmen M. Ortiz similarly said that personnel from her office and law enforcement partners were investigating allegations concerning the company. She added that it was "entirely premature" to suggest what the results of that probe may be.

    More at link......


    "The further we (as the human race) grow away from the natural world, the quieter the natural world becomes and the more pathological we become as a culture."........Bernie Krause

    The citizens of the United States of America have a right to applaud themselves for having given to mankind examples of an enlarged and liberal policy—a policy worthy of imitation......which gives to bigotry no sanction, to persecution no assistance.......George Washington

  13. #13
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    Thank you sovery much! The link and then the html worked for me. I cant believe how many items are in this list...even stuff like glycerin and salicylic acid compounds! Unbelievable.

    Sent with KFire via Tap-a-Talk

  14. #14
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    Compounding Center’s License Revoked

    http://www.wbjournal.com/apps/pbcs.d...121029982/1002

    State regulators have voted to permanently revoke the license of the Framingham pharmacy at the center of nationwide outbreak of fungal meningitis, and Gov. Deval Patrick on Tuesday said the state would begin periodic, unannounced inspections of similar labs operating in Massachusetts.

    The Department of Public Health released the preliminary finding of its month-old, ongoing investigation into the New England Compounding Center on Tuesday, and Bureau of Health Care Safety and Quality Director Madeleine Biondolillo reported "several health and safety deficiencies" at the drug compounding pharmacy.......more at link.....


    "The further we (as the human race) grow away from the natural world, the quieter the natural world becomes and the more pathological we become as a culture."........Bernie Krause

    The citizens of the United States of America have a right to applaud themselves for having given to mankind examples of an enlarged and liberal policy—a policy worthy of imitation......which gives to bigotry no sanction, to persecution no assistance.......George Washington

  15. #15
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    just got this email with link

    http://www.fda.gov/NewsEvents/Newsro...ce=govdelivery

    DA reports conditions observed at New England Compounding Center facility
    10/26/2012 01:58 PM EDT

    Today, the U.S. Food and Drug Administration released a copy of the FDA Form 483 issued to the New England Compounding Center (NECC). The FDA observed and has since confirmed contaminated products and listed a number of observations regarding conditions in the clean room at NECC’s Framingham, Mass. facility.

    this is what the link read

    For Immediate Release: Oct. 26, 2012
    Media Inquiries: Sarah Clark-Lynn, 301-796-9110, sarah.clark-lynn@fda.hhs.gov
    Consumer Inquiries: 888-INFO-FDA

    FDA reports conditions observed at New England Compounding Center facility

    Today, the U.S. Food and Drug Administration released a copy of the FDA Form 483 issued to the New England Compounding Center (NECC). The FDA observed and has since confirmed contaminated products and listed a number of observations regarding conditions in the clean room at NECC’s Framingham, Mass. facility.

    The investigators also observed problems with NECC’s ability to maintain its clean room, which is the enclosed space that is designed and maintained to have a controlled environment with low levels of airborne particles and surface contamination. Production of sterile drug products in a properly functioning and maintained clean room reduces the risk of the introduction of microbial contamination into the drug during processing, including filling into its final container.

    The FDA issues a 483 at the end of an inspection when the investigators believe that they observed conditions or practices that, in their judgment, may indicate violations of the Federal Food, Drug, and Cosmetic Act, or related regulations.

    The 483 does not constitute a final FDA determination that any observation listed on the 483 is a violation of the Federal Food, Drug, and Cosmetic Act or any related regulations.

    The FDA considers the 483 along with an Establishment Inspection Report (EIR), prepared by FDA investigators, and any other relevant information, including any responses received by the company. The agency then considers whether further action, if any, is appropriate. The inspection report for NECC has not been completed and is not being shared at this time.

    The FDA continues to work closely with the U.S. Centers for Disease Control and Prevention and state partners, including the Massachusetts Board of Registration in Pharmacy, to investigate the outbreak of fungal meningitis among patients who received NECC’s compounded preservative-free methylprednisolone acetate (80mg/ml), an injectable steroid.
    For more information:

    FDA Form 483 for New England Compounding Center
    FDA Form 483: Frequently Asked Questions
    FDA Inspections, Compliance, Enforcement, and Criminal Investigations
    Update on Fungal Meningitis

    The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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