News
Home >

News

2024-05-08

Taiwan Otsuka Pharmaceutical announces a voluntarily recall of Abilify 5mg & 30mg

Taiwan Otsuka Pharmaceutical hereby announces that trace residues of another drug component,
produced on the same equipment, have been detected in the ABILIFY 5mg, 10mg, 15mg, 30mg tablets
(commonly known as Otsuka Abilify Tablets, hereinafter referred to as "the product") sold in the United States.

Consequently, we will voluntarily recall the same batches of the product in Taiwan,
including 5mg (Batch No. 3G01) and 30mg (Batch Nos. 2D01 and 3A01).

We sincerely apologize for any concerns this may have caused to patients, their families, and medical professionals.

The detected quantity of the pharmaceutical ingredient is extremely small, significantly below the Permitted Daily Exposure (PDE*).
The potential for serious harm to patients' health is very low, and to date, we have not received any reports of health damage caused
by this incident.

We will further strengthen our quality control and promptly deliver the product to those in need.

*PDE (Permitted Daily Exposure): Indicates the dose that a person is exposed to every day for a lifetime without expected
harmful effects, used to calculate cleaning validation levels for shared pharmaceutical manufacturing equipment.