WHO: About one dozen companies including B. Braun, Baxter and Hospira
WHAT: Federal officials launched a crackdown this week against companies that market an eyewash and a widely used skin cream without Food and Drug Administration approval.
WHY IT HAPPENED: Many unapproved drugs predate federal regulation. The FDA estimates about 72 million prescriptions are written each year for unapproved drugs. It is a huge, unregulated market worth as much as $100 million per year.
WHY IT WAS A BAD IDEA: The FDA received more than 300 complaints of serious reactions to unapproved brands of balanced salt-solution eyewash used for keeping eyes moist during surgery. There have been about 40 reports on unapproved skin creams containing a papaya plant enzyme called papain, which is used for treating skin ulcers from diabetes and other causes.