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

Otsuka’s Economic and Health Impact in the United States report is now available. The report highlights the contributions of Otsuka’s U.S. pharmaceutical subsidiaries, Otsuka America Pharmaceutical, Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., McQuade Center for Strategic Research & Development, and Otsuka Precision Health, Inc., formerly known as Otsuka Digital Health, Inc.

Collectively, the subsidiaries comprise nearly 2,000 employees at three corporate offices and other locations in the United States. The report shows how Otsuka’s U.S. operations directly result in high-quality jobs, tax revenues, and economic output and indirectly support additional jobs and economic activity. This edition also features a case study into the benefits of diversity in clinical research and Otsuka’s innovative approach to clinical trials.

With a mission to develop products for better health worldwide, Otsuka continues to focus on areas of unmet need with a special focus on neuropsychiatric conditions and kidney diseases. While many companies have moved away from developing solutions in the complex area of neuropsychiatry, Otsuka continues to invest in uncovering therapies for those who live with mental illness.

“If there is a single truth to overcoming the mental health challenges that America faces, it is that no one entity can do it alone. We must endeavor together to empower patients, further equity in care, and address barriers to access to offer renewed hope for those living with mental illness. A world where every mind is valued,” said Tarek Rabah, president and CEO, Otsuka North America Pharmaceutical Business.

The report also demonstrates how Otsuka collaborates with patient advocacy groups and other organizations to benefit patients and reach the communities in which Otsuka-people live and work.

Report Highlights

Economic and Fiscal Impact - The economic impact analysis presented in the report is based on Otsuka’s 2022 U.S. payroll and operating expenses and shows Otsuka supported nearly 10,520 US jobs, generated more than $1.2 billion in labor income (a measure of wages), and contributed $2.7 billion in economic output. Otsuka also supports tax revenue in the United States. In 2022, tax receipts attributable to or supported by Otsuka’s economic activity totaled nearly $385 million.
 

Clinical Research Case Study - In working to bring treatments to those living with mental illness, Otsuka understands that it is critical to have diversity in research programs and clinical trials so that the outcomes are representative of the patient population who will receive a therapy. Diversity in clinical research, particularly inclusion of underrepresented communities who may be most burdened, is important to ensure equitable access to interventional therapies that may offer more viable treatment options for patients.