Otsuka is voluntarily recalling certain lots of ABILIFY® (aripiprazole) Tablets due to cross-contamination from extremely small amounts of another active pharmaceutical ingredient previously manufactured on the same equipment. Based on sample testing performed, there is no material patient risk associated with the trace level of contamination found. The voluntary recall has been initiated by Otsuka out of an abundance of caution, with the knowledge of the U.S. Food and Drug Administration. This recall is limited to the United States.

Consumers who have a product that is being recalled and who have concerns, should consult with their healthcare provider or pharmacy. Adverse reactions or quality problems experienced with the use of this product should be reported.

Otsuka America Pharmaceutical, Inc. can be reached by phone at 1-833-468-7852 Monday – Friday, 9 a.m. – 5 p.m. Eastern Time or by email: global_intake@otsuka-us.com or ProductComplaints@otsuka-us.com. The FDA's MedWatch Adverse Event Reporting program can be reached either online or by phone. To complete and submit the report Online: www.fda.gov/medwatch/report.htm or call 1-800-332-1088.

Read more here: https://www.otsuka-us.com/news/otsuka-us-voluntary-recall

April 2024 01US24EBC0008

As Vice President & Global Head of Medical & Regulatory Affairs at Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), Mary is responsible for the global medical and regulatory strategy and operations for Otsuka pharma businesses. Her experience and proven expertise navigating the global regulatory environment is critical to helping the organization shape the strategy for optimizing future successes.

With Otsuka's purpose guiding her work, Mary encourages her team to place the patients and communities we serve at the center of everything they do. Her dedication to patients and their well-being helps further our organizational commitment to patient needs.

Mary joined Otsuka in 1999 and has served in several medical and regulatory leaderships roles for products that advance therapeutic areas in which Otsuka operates. Prior to joining Otsuka, she worked at the University of Maryland School of Medicine within the Psychiatry department. She holds an undergraduate degree in pre-medicine and psychology and graduate degree in clinical neuropsychology.

At Otsuka, I believe our core values of humility and perseverance can help transform our personal and professional lives. We must strive to defy who we think we are, so that we can achieve what is seemingly impossible.