FDA halts marketing of unapproved codeine sulfate tablets

The FDA has warned four companies that they must stop marketing unapproved codeine sulfate tablets, an opioid analgesic indicated for the treatment of pain. The following products and the manufacturers and distributors that received the warning letters are:

• Codeine sulfate tablets 30mg, 60mg – Lehigh Valley Technologies
• Codeine sulfate tablets 30mg, 60mg – Cerovene 
• Codeine sulfate tablets 30mg – DAVA International 
• Codeine sulfate tablets 30mg, 60mg – Glenmark Generics

These particular products are not FDA-approved and the FDA has no evidence that they are safe and effective. Companies receiving the warning letters have 15 days to give the FDA a plan to discontinue marketing the unapproved drugs. Manufacturers have 90 days to cease manufacturing of new product, and distributors have 180 days to cease further shipment of existing products. Previously manufactured unapproved products may still be found on pharmacy shelves for a period of time. FDA-approved codeine sulfate tablets are available from Roxane Laboratories. Roxane is able to meet the demand for the drug and the FDA does not anticipate a supply problem for codeine sulfate tablets.

For more information visit www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm186418.htm.