Safety Alerts & Recalls

What does this mean?

Although this is not a recall alert, the safety of unapproved drugs is unknown and you should review your oxycodone prescription to see if is involved in this FDA warning. This warning only applies to people taking oxycodone 5 mg tablets or oral solution 20mg/ml with the brand name Roxicodone or Roxanol made by Boehringer Ingelheim Roxane Inc. or Xanodyne Pharmaceuticals Inc.

If you are taking oxycodone 5 mg tablets or oral solution 20mg/ml, look at your prescription bottle to see if it was made by one of the companies involved in the warning. The manufacturer is often listed on the prescription label. If you think you might be taking an unapproved product or if you are not sure, please bring your bottle to your pharmacy for them to examine and possibly replace.

If you have any questions about this safety alert or your use of oxycodone, please follow up with your pharmacist or doctor.

FDA Warns Companies to Stop Producing Unapproved Narcotics

The FDA recently told several companies to stop producing oxycodone because their formulation of the product has not been approved by the FDA for marketing. The following formulations and manufacturers are affected by the FDA warning: Roxanol Oral Solution, 20 mg/ml: Boehringer Ingelheim Roxane Inc. and Xanodyne Pharmaceuticals Inc.

Roxicodone Tablets, 5 mg: Boehringer Ingelheim Roxane Inc. and Xanodyne Pharmaceuticals Inc.

Oxycodone is widely used to treat pain. Other manufacturers, such as Mallinckrodt and Vintage Pharmaceuticals, have FDA approved formulations of oxycodone immediate release tablets.

For more information, please visit: more information here

Source: FDA
Publication Date: 2009-04-01
Last Updated: 2009-12-05

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