What action is FDA taking regarding drug products containing morphine sulfate, hydromorphone, or oxycodone?
The Food and Drug Administration (FDA) has sent warning letters directing companies to stop making and distributing specific narcotic products in certain dosage forms that lack the required FDA approval. Affected products include unapproved high concentrate oral solutions containing morphine sulfate and unapproved immediate release tablets containing morphine sulfate, hydromorphone, or oxycodone. Below is a list of the specific drug products involved in this action. Consumers should be aware that approved versions of these drugs will remain available. When is this action going to take effect? Manufacturers have 60 days after the dates of the Warning Letters to cease manufacturing of new product, and distributors have 90 days after the dates of the Warning Letters to cease further shipment of existing products. Previously manufactured unapproved products affected by this action may still be found on pharmacy shelves for a short period of time. Are these products recalled from the pharma
