The US FDA has warned four companies to stop marketing unapproved codeine sulfate tablets. These drugs are opioid analgesics (commonly known as narcotics) that are widely used to treat pain.
According to FDA, the products have not received its approval and the agency has no evidence that they are safe and effective.
The products and the manufacturers and distributors that received the warning letters are Codeine Sulfate Tablets, 30mg, 60mg – Lehigh Valley Technologies, Allentown, Penn, Codeine Sulfate Tablets, 30mg, 60mg – Cerovene, Valley Cottage, NY, Codeine Sulfate Tablets, 30mg – Dava International, Fort Lee, NJ, and Codeine Sulfate Tablets, 30mg, 60mg – Glenmark Generics, USA, Mahwah, NJ.
Reportedly, the companies which received the warning letters have 15 days to give the FDA a plan to discontinue marketing the unapproved drugs. The manufacturers have 90 days to cease manufacturing of new product, and distributors have 180 days to cease further shipment of existing products.
Consumers who rely on opioid analgesics for pain relief have access to products that have been evaluated by the FDA and determined to be safe and effective for use, said the FDA.
Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at FDA, 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. The FDA urges drug companies to ensure all drugs they make and market have appropriate FDA approval.”