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.
A Novel, Enhanced, and Sustainable Approach to Audit Trail Review
July 4th 2025Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.