FDA Warns Eyedrops Contaminated with Bacteria
Miracle II Neutralizer and Miracle II Neutralizer Gel could cause severe infections
THURSDAY, Dec. 8 (HealthDay News) -- The U.S. Food and Drug Administration warned consumers this week not to use Miracle II Neutralizer and Miracle II Neutralizer Gel products because they are bacterially contaminated and could cause severe infections.
Tedco, Inc., of West Monroe, La., markets Miracle II Neutralizer for ophthalmic use, as an eyewash, and to treat conjunctivitis and cataracts, according to an FDA statement. Because of the "substantial risk" of non-sterility, Miracle II Neutralizer should never be used in the eyes, the FDA warns.
The company also markets Miracle II Neutralizer for the treatment of AIDS, cancer, diabetes, herpes and other unapproved uses. Similarly, the firm promotes Miracle II Neutralizer Gel for many of the same unapproved uses, the FDA warns.
Despite company claims of "supreme technology" and its refusal to pull the products from the market, recent tests show the products are bacterially contaminated, the FDA warned.
The FDA "will not tolerate" marketing potentially dangerous products with deceptive claims, Margaret O'K. Glavin, FDA Associate Commissioner for Regulatory Affairs, said in the statement. "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."