FDA warns companies to stop marketing unapproved balanced salt solutions

The U.S. Food and Drug Administration has warned companies that manufacture and market unapproved ophthalmic balanced salt solutions to stop manufacturing and marketing these products at the risk of enforcement action, the agency announced in a press release.

Following reports of serious adverse events associated with the use of unapproved balanced salt solutions, including eye inflammation, cloudy vision and permanent vision loss, an FDA inspection revealed contaminants and other deficiencies in the products, the release said.

As a result, the agency has advised companies to halt manufacturing these products by Nov. 24 and to discontinue their delivery by Jan. 21, 2009. Companies that continue to market unapproved irrigating solution products after these dates may be subject to immediate seizure or injunction.

The FDA urged physicians and other consumers to use approved balanced salt solutions manufactured by Alcon and Akorn, according to the release.