1/19/12 The U.S. Food and Drug Administration, or FDA, has issued a public health advisory for certain opioid analgesics made by Endo Pharmaceuticals. The affected products are Opana, Opana ER, oxymorphone hydrochloride tablets CII, Percocet, Percodan, Endocet, Endodan, morphine sulfate extended-release tablets CII, and Zydone.
Because of a problem at a Novartis-owned manufacturing plant, which makes and packages these medications for Endo Pharmaceuticals, stray tablets may have been packaged with these products. The FDA and Endo Pharmaceuticals say the likelihood of a packaging error is low. Since 2009 there have been only three product mix-ups involving these medications reported, all of which were detected by pharmacists. For more information, click here.
Nonetheless, patients are advised to examine their opioid medication to ensure that all the tablets are the same and to ask their pharmacists if they have any doubts. Click here to download a visual guide to help identify medications. Patients with additional questions or concerns can contact Endo customer service at 800/462-3636.
The Lincoln, Neb., facility has temporarily suspended operations and shipments, and Endo Pharmaceuticals reports that there may be short-term shortages of the affected medications. The FDA is working with Novartis and Endo to address the problem.
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Thank you for your kind attention.
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