Potential Mix-up in Opiate Tablets

Tablets from one opiate medicine may have ended up in the bottle of another one due to problems that occurred during packaging and labeling. The products affected are manufactured and packaged for Endo Pharmaceuticals by Novartis Consumer Health Inc. and include: • Opana ER (oxymorphone hydrochloride) Extended-Release Tablets CII • Opana (oxymorphone hydrochloride) Tablets CII • Oxymorphone hydrochloride Tablets CII • Percocet (oxycodone hydrochloride and acetaminophen, USP) Tablets CII • Percodan (oxycodone hydrochloride and aspirin, USP) Tablets CII • Endocet (oxycodone hydrochloride and acetaminophen, USP) Tablets CII • Endodan (oxycodone hydrochloride and aspirin, USP) Tablets CII • Morphine Sulfate Extended-Release Tablets CII • Zydone (hydrocodone bitartrate/acetaminophen tablets, USP) CIII Opiates are strong medications used to alleviate pain and are available only by prescription. In the coming weeks, FDA expects there will be shortages of these medications while the manufacturing issues are resolved. The agency is working with Endo Pharmaceuticals and Novartis to minimize the impact to consumers. The extent of the shortage will depend upon how quickly safeguards can be put in place to prevent this mix-up from happening again and then how soon manufacturing can be restarted. Recommendations •Examine all opiate medicines made by Endo Pharmaceuticals to ensure that all the tablets are the same and match the pictures of tablets in the visual guide Click Here •Bring your medicine bottle to your pharmacist and do not take any of the tablets if: •one or more tablets in your bottle look different from the others •there are tablets that are different in shape, color or size, or the markings are different •If you have questions about your medicine, call your pharmacist or health care professional, or call Endo Pharmaceuticals at 800-462-3636. •Dispose of any unused opiate tablets according to FDA’s recommendations Click Here
http://www.fda.gov/Drugs/DrugSafety/ucm286226.htm