[21 November 2011]
Products Affected - Description
Roxicodone Immediate-Release Solution, Xanodyne
20 mg/mL solution, 30 mL (NDC 66479-0584-03) – discontinued
5 mg/5 mL solution, 40 mL unit dose (NDC 66479-0583-05) – discontinued
5 mg/5 mL solution, 500 mL (NDC 66479-0583-50) – discontinued
Oxycodone Immediate-Release Solution, Mallinckrodt
20 mg/mL solution, 30 mL (NDC 00406-8558-30) – discontinued
5 mg/5 mL solution, 500 mL (NDC 00406-8555-50) – discontinued
Reason for the Shortage
- Mallinckrodt has discontinued their oxycodone solution.
- Xanodyne discontinued their Roxicodone oral solution in December, 2010.
- Lannett had product temporarily unavailable to comply with their DEA supply quota.
- Lehigh Valley Technologies received FDA approval for their oxycodone solution product. All other currently manufactured oxycodone solution products are not approved by FDA and no FDA action has been taken against manufacturers that continue to market these products. The product will be distributed by Glenmark.
Oxycodone Immediate-Release Solution, Glenmark
20 mg/mL solution, 30 mL (NDC 68462-0347-37)
Oxycodone Immediate-Release Solution, VistaPharm
5 mg/5 mL solution, 5 mL unit-dose cups (NDC 66689-0024-50)
5 mg/mL solution, 500 mL bottles (NDC 66689-0024-16)
Oxycodone Immediate-Release Solution, Lannett
20 mg/mL solution, 30 mL (NDC 00527-1426-36)
Estimated Resupply Dates
All presentations are available.
November 21, 2011; October 26, 2011; September 27, 2011; September 7, 2011; August 31, 2011; August 25, 2011; July 22, 2011; May 5, 2011; February 23, 2011; January 28, 2011; December 17, 2010; November 17, 2010; October 21, 2010; October 19, 2010; September 29, 2010; August 25, 2010, University of Utah, Drug Information Service. Copyright 2011, Drug Information Service, University of Utah, Salt Lake City, UT.
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