US Pharm. 2009;34(11):24.
The FDA warned four companies that they must stop marketing unapproved codeine sulfate tablets, opioid analgesics used to treat pain. These particular products have not received FDA approval, and the agency has no evidence that they are safe and effective. Another manufacturer, Roxane Laboratories, markets approved codeine sulfate tablets, and the FDA does not expect a shortage in the supply of these drugs.
The products and the manufacturers and distributors that received the warning letters are: Codeine Sulfate Tablets, 30 mg, 60 mg (Lehigh Valley Technologies Inc., Allentown, Pennsylvania); Codeine Sulfate Tablets, 30 mg, 60 mg (Cerovene Inc., Valley Cottage, New York); Codeine Sulfate Tablets, 30 mg (Dava International Inc., Fort Lee, New Jersey); and Codeine Sulfate Tablets, 30 mg, 60 mg (Glenmark Generics Inc. USA, Mahwah, New Jersey). Companies receiving the warning letters have 15 days to give the FDA a plan to discontinue marketing the unapproved drugs.
