FDA: Product promoted for eye care not sterile
The product is sold as Miracle II Neutralizer.
WASHINGTON (AP) -- The Food and Drug Administration is warning 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 things, as an eyewash and a treatment for cataracts and pinkeye. 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.
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