FDA Warns Consumers About Bacterially-Contaminated Miracle II Neutralizer and Gel

Discussion in 'Food and nutrition' started by Lisa Ruby, Dec 15, 2005.

  1. Lisa Ruby

    Lisa Ruby Guest

    December 6, 2005

    Media Inquiries:
    Rae Jones, 301-827-6242
    Consumer Inquiries:

    FDA Warns Consumers About Unapproved and Bacterially-Contaminated
    Miracle II Neutralizer and Miracle II Neutralizer Gel Drug Products

    Use of Products Could lead to Severe Infections

    The Food and Drug Administration (FDA) is advising consumers not to use
    Miracle II Neutralizer and Miracle II Neutralizer Gel products
    manufactured by Tedco, Inc., in West Monroe, Louisiana because the
    products are bacterially contaminated and have not been proven to be
    safe and effective. Use of these products could pose a risk of serious
    adverse events such as infections, particularly in children, the
    elderly, and individuals with weakened immune systems who are
    particularly susceptible to illness.

    "We will not tolerate the marketing of products that use deceptive and
    untruthful claims to lure consumers into potentially dangerous
    situations," said Margaret O'K. Glavin, FDA's Associate Commissioner
    for Regulatory Affairs. "We consider it a significant public health
    hazard when consumers are deliberately deceived into using potentially
    dangerous products that promise health benefits but deliver only risk
    of harm."

    Tedco, Inc., promotes Miracle II Neutralizer for ophthalmic use (in the
    eyes), including treatment of cataracts and pink eye, and as an
    eyewash. FDA requires that all ophthalmic products be sterile. Due to
    the substantial risk posed by non-sterility, Miracle II Neutralizer
    should never be applied to the eyes.

    Tedco, Inc., also markets Miracle II Neutralizer for other unapproved
    uses, including treatment of AIDS, cancer, Crohn's Disease, dermatitis,
    diaper rash, diabetes, ear ache, hemorrhoids, hives, gout, herpes,
    mouth ulcers, psoriasis, skin cancer, and yeast infection. The firm
    sells Miracle II Neutralizer Gel for many of the same unapproved uses,
    including diaper rash, diabetes, gout, psoriasis, and skin cancer.

    Tedco, Inc., promotes its Miracle II products with claims such as,
    "Supreme technology has made possible for a perfect soap cleaner,
    deodorizer, natural insecticide and antibacterial product to be put on
    the market. This is the only product that is made in the world that can
    wash a newborn baby or clean up an oil spill and everything in
    between." Contrary to such claims, recent FDA testing of Miracle II
    Neutralizer and Miracle II Neutralizer Gel revealed bacterial
    contamination and poor manufacturing conditions.

    Although Tedco, Inc., has been advised by FDA of the contamination
    found in its Miracle II Neutralizer and Miracle II Neutralizer Gel
    products, the firm has declined to voluntarily remove the products from
    the market.

    A number of stores sell Miracle II Neutralizer and Miracle II
    Neutralizer Gel, and the products are distributed and sold worldwide
    and sold via the Internet. The products are packaged in 8 oz, 22 oz,
    and one-gallon size containers.

    FDA urges consumers, health care providers, and caregivers to cease
    using and dispose of these products and report any adverse events
    related to these products to MedWatch, the FDA's voluntary reporting
    program at 1-800-FDA-1088; by FAX at 1-800-FDA-0178; by mail to
    MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville,
    MD, 20857-9787; or online at www.fda.gov/medwatch/report.htm.



    posted by Lisa Ruby