Roxane Labs Recalls Azathioprine Tablets

July 20, 2006
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

Roxane Laboratories (Columbus, OH), a Boehringer Ingelheim company, is conducting a voluntary recall in the United States and Puerto Rico of a single manufacturing lot of "Azathioprine"tablets, USP 50 mg.

Roxane Laboratories (Columbus, OH, www.roxane.com), a Boehringer Ingelheim company,is conducting a voluntary recall in the United States and Puerto Ricoof a single manufacturing lot of azathioprine tablets, USP 50 mg. Thecompany ordered the recall after discovering that a single bottleof azathioprine, which had not been dispensed to a patient, containedMethotrexate tablets, USP 2.5 mg, which would cause "serious toxiceffects" and even death at high doses, if taken in accordance withdosing instructions that may be prescribed for azathioprine. The companyis working with FDA on this recall, and no related injuries have beenreported to date.