Reason for the Shortage
Novartisvoluntarily suspended all manufacturing and distribution from its Lincoln, Nebraska facility in early-January 2012 due to a potential for mixing of different products within a single bottle. Novartis is gradually resuming manufacturing at this facility after manufacturing improvements were implemented.
SeveralEndo products that are manufactured at the Lincoln, Nebraska plant, are affected by this manufacturing suspension, including oxymorphone, Opana, and Opana ER.
Roxane could not provide a reason for this shortage.
Available Products
Extended-Release Presentations
Opana ER, Endo
5 mg tablets, 100 count (NDC 63481-0907-70)
10 mg tablets, 100 count (NDC 63481-0674-70)
20 mg tablets, 100 count (NDC 63481-0617-70)
30 mg tablets, 100 count (NDC 63481-0571-70)
40 mg tablets, 100 count (NDC 63481-0693-70)
Oxymorphone extended-release, Actavis
7.5 mg tablets, 100 count (NDC 00228-3261-11)
15 mg tablets, 100 count (NDC 00228-3262-11)
Immediate-Release Presentations
Oxymorphone, Roxane
5 mg tablets, 100 count (NDC 00054-0283-25)
10 mg tablets, 100 count (NDC 00054-0284-25)
Estimated Resupply Dates
Endo has Opana immediate-release tablets on long term back order and the company cannot estimate a release date.
Qualitest has oxymorphone immediate-release tablets on back order and the company cannot estimate a release date.