January 9, 2012
FDA has issued a public health advisory and Endo Pharmaceutical has released a press announcement on Endo Pharmaceuticals’ opiate and opiate containing medications. There is a potential shortage of Endo’s opiate and opiate containing medications due to a temporary shut-down of their contract manufacturing facility in Lincoln, Nebraska. One of the issues being addressed is the potential for errors in packaging of opiate and opiate-containing medications. There have only been 3 mix-ups of medication since 2009. All 3 reports were caught by pharmacists and none of the affected product reached patients. There is no recall on these products as the risk is low, and a recall may precipitate a shortage. The company is providing visual aids to help healthcare professionals and consumers verify the products they are using. Letters and visual aids are available on the Endo website http://endo.com/Supply_disruption.aspx. The products affected by this issue include:
- Opana® (oxymorphone hydrochloride) tablets
- Oxymorphone hydrochloride tablets
- Percocet® (oxycodone hydrochloride and acetaminophen USP) tablets
- Percodan® (oxycodone hydrochloride and aspirin, USP) Tablets
- Endocet® (oxycodone hydrochloride and acetaminophen USP) tablets
- Endodan® (oxycodone hydrochloride and aspirin, USP) tablets
- Morphine sulfate extended-release tablets
- Zydone® (hydrocodone bitartrate/acetaminophen tablets, USP)
Percocet and Endocet are now being manufactured by another facility and the manufacturer hopes the supply disruption will be minimal. Opana ER is not supplied by other facilities or manufacturers and the company recommends healthcare professionals not start new patients on this product until the manufacturing issues have been resolved.
Report any adverse events associated with the use of any of these opiate products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
Additional information is available at the following links:
- FDA Medwatch:
- FDA Public Health Advisory:
- Endo News Release:
- Endo Letters and Visual Aids:
January 9, 2012; University of Utah, Drug Information Service. Copyright 2012, Drug Information Service, University of Utah, Salt Lake City, UT.