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March 25 Update on Oxycodone Shortage

cherish22ccherish22 Posts: 706
edited 06/20/2016 - 9:58 AM in Pain Management
 Oxycodone Tablets, Capsules, and Solutions

25 March 2009

Products Affected - Description

Immediate Release Tablets
Oxycodone Immediate-Release Tablets, Actavis
5 mg, 100 count (NDC 52152-0165-02) - discontinued
15 mg, 100 count (NDC 52152-0214-02)
15 mg, unit dose, 100 count (NDC 52152-0214-11)
30 mg, 100 count (NDC 52152-0215-02)
30 mg, unit dose, 100 count (NDC 52152-0215-11)

Oxycodone Immediate-Release Tablets, Ethex
5 mg, 100 count (NDC 58177-0315-04) - discontinued
5 mg, unit dose, 100 count (NDC 58177-0315-11) - discontinued
5 mg, 100 count (NDC 58177-0625-04) - discontinued
5 mg, unit dose, 100 count (NDC 58177-0625-11) - discontinued
15 mg, 100 count (NDC 58177-0445-04) - discontinued
30 mg, 100 count (NDC 58177-0446-04) - discontinued

Oxycodone Immediate-Release Tablets, Mallinckrodt
5 mg, 100 count (NDC 00406-0552-01)
5 mg, unit dose, 100 count (NDC 00406-0552-62)
15 mg, 100 count (NDC 00406-8515-01)
30 mg, 100 count (NDC 00406-8530-01)

Oxycodone Immediate-Release Tablets, Qualitest
15 mg, 100 count (NDC 00603-4991-21)
30 mg, 100 count (NDC 00603-4992-21)

Roxicodone Immediate-Release Tablets, Xanodyne
5 mg, 100 count (NDC 66479-0580-10)
5 mg, unit dose, 100 count (NDC 66479-0580-25)
15 mg, 100 count (NDC 66479-0581-10)
30 mg, 100 count (NDC 66479-0582-10)

Immediate Release Capsules
Oxycodone Immediate-Release Capsules, Ethex
5 mg, 100 count (NDC 58177-0041-04) - discontinued
5 mg, unit dose, 100 count, NDC 58177-0041-11 - discontinued

Oxycodone Immediate-Release Capsules, Mallinckrodt
5 mg, 100 count (NDC 00406-0554-01)

Immediate Release Solution
Oxycodone Immediate-Release Solution, Mallinckrodt
5 mg/5mL solution, 500 mL (NDC 00406-8555-50)
20 mg/mL solution, 30 mL (NDC 00406-8558-30)

Oxycodone Immediate-Release Solution, Lannett
20 mg/mL solution, 30 mL (NDC 00527-1426-36)

Roxicodone Immediate-Release Solution, Xanodyne
5 mg/5 mL solution, unit-dose, 40 mL (NDC 66479-0583-05)
5 mg/5 mL solution, 500 mL (NDC 66479-0583-50)
20 mg/mL, 30 mL (NDC 66479-0584-03)
Reason for the Shortage

* In December, 2008, KV Pharmaceuticals, which markets prescription medications through Ethex, voluntarily suspended shipment of all prescription tablet products (http://www.kvpharmaceutical.com/news_center_article.aspx?articleid=276). In early 2009, FDA filed an injunction against KV Pharmaceuticals preventing the company from manufacturing any products until all issues are resolved.
* Actavis states the shortage is due to manufacturing issues. Actavis has also discontinued manufacturing their oxycodone 5 mg tablet.
* Mallinckrodt, Qualitest, and Xanodyne are having supply and demand issues.

Estimated Resupply Dates

Tablets

* Xanodyne has all presentations of Roxicodone tablets on intermittent back order and are releasing supplies as they come in.
* Mallinckrodt has all of their oxycodone immediate-release tablets, capsules, and solution on intermittent back order and are releasing supplies as they come in.
* Qualitest is shipping oxycodone immediate-release 15 mg and 30 mg tablets as product becomes available.
* Actavis has their oxycodone immediate-release tablets on a long-term back order and the company cannot estimate a release date.

Capsules

* Glenmark was not available for contact regarding product availability.
* Mallinckrodt has their oxycodone immediate-release 5 mg capsules on intermittent back order and are releasing supplies as they come in.
* Purdue has their OxyIR immediate-release 5 mg capsules (NDC 59011-0201-10) available.

Solution

* Mallinckrodt has their oxycodone 5 mg/5 mL solution in 500 mL size and the 20 mg/mL solution in 30 mL size on intermittent back order and are releasing supplies as they come in.
* Xanodyne has all presentations of Roxicodone solution on intermittent back order and are releasing supplies as they come in.
* Lannett has their oxycodone 20 mg/mL solution on back order with an estimated release date of mid- to late-April, 2009.
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Comments

  • Wow, cherish, I didn't know anything about this. I take the 5/325 mg tablet of Oxycodone-APAP made by Mallinckrodt. I just refilled my monthly supply, and thankfully, there was no problem. It doesn't say it affects the APAP combinations, but should I assume it does? Sure hope I don't have problems next month, and down the line...

    Thanks for the info,
    rubybear
  • actually what you have is hydrocodone, it's the generic for Vicodin, oxycodone is a different pain drug.
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