What action is FDA taking regarding codeine sulfate tablets?
The Food and Drug Administration (FDA) has sent Warning Letters directing companies to stop making and distributing 30 mg and 60 mg codeine sulfate tablets that lack the required FDA approval. Table 1 provides a list of the specific unapproved drug products involved in this action. When is this action going to take effect? Manufacturers have 90 days after the date of their Warning Letter to stop manufacturing new products, and distributors have 180 days after the date of their Warning Letter to stop further shipment of existing products. Are these products recalled from the pharmacy? No, this is not a recall. Previously manufactured unapproved products affected by this action may still be found on pharmacy shelves for a short period of time until the inventory has been depleted or the product has become expired, whichever occurs first. Why is FDA taking this action? FDA is taking this action as part of its continuing effort to ensure that drugs marketed in the U.S. have the required FD
