The US Food and Drug Administration (FDA) recently announced that companies marketing unapproved ophthalmic balanced salt solutions (BSS) and unapproved topical drug products containing papain must stop manufacturing and marketing these products or risk enforcement action. The FDA is taking these actions because it has received reports of serious adverse events associated with the products’ usage.

Companies must stop manufacturing unapproved BSS products on or before November 24, 2008, and must stop shipping such unapproved products on or before January 21, 2009. Companies marketing any unapproved topical drug products containing papain must stop manufacturing them on or before November 24, 2008. Companies engaged in shipping these products must stop shipping these products on or before January 21, 2009. After these dates, all unapproved BSS products must have FDA approval to be manufactured or shipped in interstate commerce. Companies that continue to market unapproved BSS products after these dates may be subject to immediate FDA enforcement action such as seizure and/or injunction against the company.

For more information, visit http://www.fda.gov/bbs/topics/NEWS/2008/NEW01890.html.