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 hydromorphone prescription to see if is involved in this FDA warning. This warning only applies to people taking hydromorphone 2 mg or 4 mg tablets made by Lannett Company, Inc., Physicians Total Care, Inc., or Roxane Laboratories, Inc.

If you are taking hydromorphone in the form of 2 mg or 4 mg tablets, 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 hydromorphone, 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 hydromorphone 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: Hydromorphone Tablets, 2 mg and 4 mg: Lannett Company, Inc., Physicians Total Care, Inc., and Roxane Laboratories, Inc.

Hydromorphone is widely used to treat pain. Other manufacturers, such as Abbott and Mallinckrodt, have FDA approved formulations of hydromorphone tablets. The FDA has determined that removal of unapproved products will not create a shortage of hydromorphone for consumers.

For more information, please visit: more information here

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