Eyewash Brand Is Tainted, FDA Cautions
Wednesday, December 7, 2005
The Food and Drug Administration warned consumers not to use Tedco Inc.'s Miracle II Neutralizer products, saying the products have been contaminated by bacteria.
Using them could lead to infections, particularly in children, the elderly and people with weakened immune systems, the FDA said.
Tedco, based in West Monroe, La., markets Miracle II Neutralizer, among other products, as an eyewash and a treatment for cataracts and pink eye. But the products are not sterile, as the FDA requires for all eye treatment products, the agency said.
The company promotes the product for treatment for a range of problems, from AIDS to diaper rash, uses that have not been approved by the FDA. It also sells a gel promoted for many of the same uses.
"Contrary to such claims, recent FDA testing of Miracle II Neutralizer and Miracle II Neutralizer Gel revealed bacterial contamination and poor manufacturing conditions," the agency said.
The product is sold in stores and on the Internet. The company has declined the FDA's appeal to voluntarily remove its products from the market.