Mix-up Prompts Azathioprine Recall (Oct. 2006)

In July, Roxane Laboratories recalled one lot of 50 mg Azathioprine tablets because the bottles in this lot may actually contain Methotrexate. Azathioprine is used to help prevent rejection in kidney transplant patients, and can also be used to manage severe rheumatoid arthritis.

If Methotrexate is taken instead of Azathioprine, serious toxic effects may occur, such as decreased resistance to infection, reduced blood counts, or liver, kidney or lung injury. Deaths have also been reported at high doses of Methotrexate - the kinds of doses that might result from substituting of Methotrexate 2.5 mg tablets for Azathioprine 50 mg tablets.

The affected lot number is 558470A (Expiration date -- March 2009). One bottle from this lot was discovered to contain 2.5 mg Methotrexate tablets instead of Azathioprine.

Roxane Laboratories says that pharmacists and wholesalers who have any bottles of Azathioprine from this lot should stop distributing them. Pharmacists who may have dispensed Azathioprine from this lot should contact the affected patients to assure they didn't receive Methotrexate tablets.

Patients who have been notified by their pharmacist that they may have received medication from the recalled lot should return the Azathioprine to their pharmacist. Patients who aren't notified should visually inspect their Azathioprine tablets. If the tablets are marked with the number 54 323, patients should not take them and immediately contact the pharmacist or physician. For more information, contact Roxane Laboratories Technical Product Information at
800-962-8364.

Additional Information:

FDA MedWatch Safety Alert 2006 -- Azothioprine. July 13, 2006.
http://www.fda.gov/medwatch/safety/2006/safety06.htm#azathioprine

Category:

News & Politics

Tags:

• Recall
• Azathioprine
• FDA
• Methotrexate
• Kidney
• Transplant
• Rheumatiod
• Arthritis
• Death
• Patient
• Safety