Folks, every once in a while the FDA does what it is supposed to do.
sol
FDA Press Release
This listserv covers mainly Class I (life-threatening) recalls. A complete
listing of recalls can be found in the FDA Enforcement Report at:
http://www.fda.gov/opacom/Enforce.html
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
http://www.fda.gov/medwatch/report.htm.
####
FDA's Recalls, Market Withdrawals and Safety Alerts Page:
http://www.fda.gov/opacom/7alerts.html
--
Whenever you find you are on the side of the majority, it is time to pause and reflect. Mark Twain
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