More than 1.78 million tablets of an antipsychotic medication have been recalled due to cross-contamination of pharmaceutical ingredients during the manufacturing process, the Food and Drug Administration (FDA) said on Tuesday.
A batch of 5mg Otsuka Abilify (aripiprazole) tablets, or more than 1.43 million doses, and two batches of Otsuka Ability (aripiprazole) 30mg tablets, or about 354,410 doses, have been recalled, the FDA said.
The medication is used to treat several mental health conditions, including schizophrenia, bipolar disorder, autism spectrum disorder and Tourette’s syndrome.
Photo courtesy of the Food and Drug Administration
On April 25, routine monitoring of international alerts showed that the US 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 an active pharmaceutical ingredient during the manufacturing process, FDA Deputy Director-General Wang Te-yuan (王德原) said.
Insufficient cleaning of equipment at the production site was the likely cause, Wang said.
The two forms of the medication are widely used in Taiwan.
More than 7.59 million 5mg tablets were used in Taiwan in 2022, while NHI reimbursement applications tallied about 238,000 30mg tablets, a National Health Insurance Administration report said last year.
Aripiprazole is an active ingredient used to treat schizophrenia in adults and adolescents, and for bipolar disorder in children aged 10 to 17, the FDA said.
It is also used to treat irritability associated with autistic disorder in pediatric patients aged six to 17, it said.
Separately, the FDA said that fresh strawberries from Japan would remain subject to batch-by-batch border inspections after a new shipment was found to contain a pesticide that is banned in Taiwan.
The shipment of 24kg of strawberries from Momofuku Shoji Co would either be returned to the country of origin or destroyed, it said.
Sample testing on April 17 found that the strawberries contained 0.04 parts per million of acrinathrin, a synthetic pyrethroid that has a high insecticidal activity against a range of insects, including mites.
Acrinathrin is a banned pesticide that cannot be used on strawberries in Taiwan, FDA Deputy Director-General Lin Chin-fu (林金富) said.
Of the 812 batches of Japanese strawberries inspected from Oct. 29 last year to April 29, 32 failed to meet Taiwan’s safety standards, mostly because they were found to have excessive levels of pesticide residue, Lin said.
Since June 1 last year, fresh strawberries from Japan have been subject to 100 percent checks at the border, a measure that was supposed to be lifted at the end of last month, Lin said.
However, because shipments of strawberries continue to fail safety inspections, every shipment of imported Japanese strawberries would be inspected until Dec. 31, he said.
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