FDA targets unapproved oxycodone products

July 11, 2012

FDA is ridding the market of single-ingredient oxycodone capsules that are being distributed without an FDA-approved application.

FDA is ridding the market of single-ingredient oxycodone capsules and oral liquids that are being distributed without an FDA-approved application.

“Action will be taken against companies that manufacture the unapproved oxycodone products on or after August 20, 2012, or that ship unapproved products on or after October 4, 2012,” according to a statement from the American Society of Health-Systems Pharmacists about the FDA action.

FDA is targeting select single-ingredient, immediate-release oxycodone hydrochloride capsules and oral liquids that do not have an FDA-approved application, such as: 5 mg and 20 mg/mL oral solution by Lannett Company; 5 mg capsules, 1 mg/mL oral solution, and 20 mg/mL oral solution by Mallinckrodt; and 5 mg capsules by Physicians Total Care.

The agency is concerned about the products’ labeling. For example, the labeling for the unapproved 20 mg/mL oral solution does not state that the oxycodone concentrate is for use only by opioid-tolerant patients.