Washington -- The U.S. Food and Drug Administration ordered four companies Tuesday to stop marketing codeine sulfate tablets that have not received FDA approval.
FDA officials said the regulatory agency has no evidence the narcotic analgesic tablets used to treat pain are safe or effective. Another manufacturer, Roxane Laboratories, markets FDA-approved codeine sulfate tablets and is able to meet the demand for the drug, officials said.
"Consumers deserve and expect that their drugs meet modern FDA standards for safety, effectiveness, labeling and quality. Removing unapproved products that do not meet those standards is an FDA priority," said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.
