SAFETY ALERT: Packaging Errors for Opiate Products from Endo by Novartis Consumer Health

The FDA has notified healthcare professionals and patients of medication mix-ups of opiate products manufactured and packaged for Endo by Novartis Consumer Health. Packaging problems have occurred at the manufacturing site and have resulted in tablets from one product type being carried over into the packaging of another product. Pharmacists are advised to perform a visual inspection when dispensing the affected products, which includes verifications of bottles that have never been opened when the entire bottle is being dispensed.

Endo has provided a visual guide to help identify incorrect tablets: www.endo.com/pdf/Supply_disruption/Visual_Guide.pdf.

The following products may be affected:
•    Opana ER (oxymorphone hydrochloride) extended-release tablets
•    Opana (oxymorphone hydrochloride) tablets
•    Oxymorphone hydrochloride tablets
•    Percocet (oxycodone hydrochloride and acetaminophen) tablets
•    Percodan (oxycodone hydrochloride and aspirin) tablets
•    Endocet (oxycodone hydrochloride and acetaminophen) tablets
•    Endodan (oxycodone hydrochloride and aspirin) tablets
•    Morphine sulfate extended-release tablets
•    Zydone (hydrocodone bitartrate/acetaminophen) tablets

Endo and Novartis are expecting a period of shortages for these products, but are working with the FDA to minimize the degree of impact.

For more information, visit www.fda.gov/Drugs/DrugSafety/ucm286226.htm.