L
Lisa Ruby
Guest
FOR IMMEDIATE RELEASE
P05-95
December 6, 2005
Media Inquiries:
Rae Jones, 301-827-6242
Consumer Inquiries:
888-INFO-FDA
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.
####
http://www.fda.gov/bbs/topics/NEWS/2005/NEW01268.html
posted by Lisa Ruby
http://www.libertytothecaptives.net
P05-95
December 6, 2005
Media Inquiries:
Rae Jones, 301-827-6242
Consumer Inquiries:
888-INFO-FDA
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.
####
http://www.fda.gov/bbs/topics/NEWS/2005/NEW01268.html
posted by Lisa Ruby
http://www.libertytothecaptives.net