Sol, This maybe true, and hopefully is; but what are they basing this recall on... batches at the plant before being shipped. Guess I'm becoming more and more skeptically about things.
connie On Tue, 06 Dec 2005 15:59:06 -0700 sol <sol...@sweetwaterhsa.com> writes: > 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 > > > -- > The Silver List is a moderated forum for discussing Colloidal > Silver. > > Instructions for unsubscribing are posted at: http://silverlist.org > > To post, address your message to: silver-list@eskimo.com > > Address Off-Topic messages to: silver-off-topic-l...@eskimo.com > > The Silver List and Off Topic List archives are currently down... > > List maintainer: Mike Devour <mdev...@eskimo.com> > > > >
