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.
Companies receiving the warning letters have 15 days to submit a plan to discontinue marketing the unapproved drugs, the FDA said. Manufacturers have 90 days to cease manufacturing of new product, and distributors have 180 days to cease further shipment of existing products.
The warning letters were sent to Lehigh Valley Technologies Inc. of Allentown, Pa.; Cerovene Inc. of Valley Cottage, N.Y.; Dava International Inc. of Fort Lee, N.J.; and Glenmark Generics Inc. USA of Mahwah, N.J.