WASHINGTON (AP) - The Food and Drug Administration is cracking down on an unapproved skin cream and eye wash.
The agency is threatening to seize the products and take legal action against the companies marketing them without government approval.
The eye wash, known as a balanced salt solution, is used to keep the eyes moist during surgery. Two companies, Alcon Laboratories and Akorn, have officially approved products that are not affected. But the FDA says three other firms are selling similar types of eye wash without federal validation of their safety and effectiveness.
The skin cream contains an enzyme called papain, derived from the tropical papaya plant, and is used to treat skin ulcers from diabetes and other causes. About a dozen companies market such creams in a lucrative business worth about $50 million a year.
The FDA says it's received more than 300 reports of serious reactions to the eye wash, and about 40 reports on the papaya creams.