The FDA has warned nine companies to stop manufacturing and distributing 14 unapproved narcotic drugs that are marketed in several dosage forms and are widely used to treat pain. The unapproved products include high concentrate morphine sulfate oral solutions and immediate release tablets containing morphine sulfate, hydromorphone, or oxycodone. This action does not include oxycodone capsules. The companies receiving warning letters are Boehringer Ingelheim, Roxane, Cody Laboratories, Glenmark Pharmaceuticals, Lannett Company, Lehigh Valley Technologies, Mallinckrodt, Physicians Total Care, Roxane Laboratories, and Xanodyne Pharmaceuticals.
Manufacturers have 60 days to cease manufacturing, and distributors have 90 days to cease further shipment of existing products. Previously manufactured unapproved products may still be found in pharmacies for a short period of time. Consumers who may be concerned that they are taking any of these products should consult their healthcare professional.
For more information visit www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149553.htm.