The U.S. Food and Drug Administration (FDA) and Roxane Labs have issued a nationwide recall of 50mg Azathioprine tablets, which are used in patients with severe rheumatoid arthritis as well as in kidney transplant patients to prevent rejection.
“It was discovered that a single bottle of Azathioprine tablets from lot 558470A contained Methotrexate tablets USP 2.5 mg. While we believe this issue may be limited to this single bottle, which was not dispensed to a patient, the decision was made to recall manufacturing lot 558470A in order to preclude any possibility of another such bottle being dispensed or used,” the FDA said.
The recall alert also said that if Methotrexate 2.5 mg tablets are taken in place of Azathioprine 50 mg tablets there could be serious adverse effects.
“Effects may include decreased resistance to infection, mouth ulcers, reduced blood counts, vomiting, diarrhea, liver, kidney or lung injury. There have also been reports of death at high doses of Methotrexate, such as might result from a substitution of Methotrexate 2.5 mg tablets for Azathioprine 50 mg tablets,” it warned.