Over 1.78 million antipsychotic medication tablets recalled

Taipei, May 7 (CNA) The Taiwan Food and Drug Administration (TFDA) on Tuesday announced a recall of over 1.78 million tablets of an antipsychotic medication due to cross-contamination from another pharmaceutical ingredient during the manufacturing process.

According to the recall notice issued by the TFDA, the affected products include a batch of 5 milligram (mg) Otsuka Abilify (aripiprazole) tablets totaling over 1.43 million doses and two batches of Otsuka Ability (aripiprazole) 30 mg tablets totaling 354,410 doses.

The antipsychotic medication is used to treat several kinds of mental health conditions, including schizophrenia, bipolar disorder, autism spectrum disorder and Tourette syndrome.

The TFDA found on April 25 when routinely monitoring international alerts that the United States Food and Drug Administration issued a recall for the two dosage forms of Otsuka Ability (aripiprazole) due to cross-contamination from extremely small amounts of another active pharmaceutical ingredient during the manufacturing process, according to TFDA Deputy Director-General Wang Te-yuan (王德原).

It is speculated that the contamination was caused by insufficient cleaning of equipment during the manufacturing process at the pharmaceutical factory, Wang said.

The two forms of the medication are widely used in Taiwan. According to the National Health Insurance Administration's statistical report for 2023, more than 7.59 million 5 mg tablets were used in Taiwan, while applications for NHI reimbursement were made for 238,000 of the 30 mg tablets.

Abilify contains the active ingredient aripiprazole which is used for the treatment of schizophrenia in adults and in adolescents 13 to 17 years of age, according to TFDA data.

Aripiprazole is also used for bipolar disorder in children aged 10-17 years. It is used for the treatment of bipolar I disorder, both as monotherapy and as an adjunct to either lithium or valproate.

It is also used to treat irritability associated with autistic disorder in pediatric patients (6-17 years of age), according to the data.