Mislabeled Azathioprine Prescriptions Recalled

Roxane Laboratories Inc. announced a voluntary recall in July of 2006 of its azathioprine tablets used to help patients from with rheumatoid arthritis. The recall was issued because a bottle containing the wrong medication was found in one lot. In particular, the recall effects 50 mg azathioprine tablets from lot 558470A with an expiration date of March 2009. Roxane publicly stated that it didn't believe the error went beyond the single mislabeled bottle, but that it opted to recall the entire product lot in the event the mistake was repeated in other units.

Azathioprine acts to inhibit purine synthesis necessary for the proliferation of cells, especially leukocytes and lymphocytes. It is an effective drug used alone to treat rheumatoid arthritis and other autoimmune diseases. It is also used with other immunosuppressants in organ transplants.

The drug misplaced in the azathioprine bottle was 2.5 mg tablets of methotrexate. Methotrexate is used to treat various forms of cancer as well as psoriasis and rheumatoid arthritis. If taken instead of the intended drug, the medication that was found could cause severe illness or death. Effects of taking the drug in place of azathioprine may include decreased resistance to infection, mouth ulcers, reduced blood counts, vomiting, diarrhea or liver, kidney or lung injury. No injuries have been reported as of yet and fortunately, the discovered bottle was not dispensed to a patient.

Pills stamped with both the numbers 54 and 323 are methotrexate tablets and should not be taken by azathioprine patients. Azathioprine patients finding such tablets should contact their pharmacist or doctor.

Article References
Drug company conducts voluntary recall of azathioprine, site accessed on 07/16/2006