TAIPEI (TVBS News) — Taiwan's Food and Drug Administration (FDA) announced a drug recall Tuesday (May 7) after receiving a notification from the U.S. FDA. The drug in question, Otsuka America Pharmaceutical's ABILIFY (aripiprazole) Tablets, used for treating schizophrenia, is suspected of being contaminated with other pharmaceutical ingredients due to unclean production lines, potentially causing complex reactions.
The affected ABILIFY tablets include both 5mg and 30mg doses across three batch numbers, with an estimated 1.789 million tablets expected to be recalled.
The main ingredient of ABILIFY® is aripiprazole, primarily used for treating schizophrenia in adults and teenagers aged 13 to 17. It can also be used as an adjunctive treatment for major depressive disorder, irritability associated with autistic disorder, and Tourette's syndrome.
FDA Deputy Director-General Wang Te-yuan stated that the Taiwan FDA received a notification from the U.S. FDA on April 25. The contamination was discovered during inspection, and it was determined that the cause was unclean production lines, leading to the mixing of other pharmaceutical ingredients.
The 5mg dose had a market share of 79.68% last year, with 7.952 million tablets claimed by the National Health Insurance, while the 30mg dose had a market share of 42.25%, with 238,457 tablets claimed.
Despite the high market share, the original manufacturer has confirmed that the current stock can be supplied by July of this year. Apart from the affected batches, the rest are circulating normally. The pharmaceutical company will also import additional drugs to make up for the recall volume, ensuring no supply shortage.
The Taiwan FDA has requested that the manufacturer complete the recall by May 26 and submit a recall report and subsequent preventive corrective measures. If patients have any concerns about their medication, they should return to their doctor as soon as possible to discuss alternative treatments. Medical institutions, drug dealers, and pharmacies are asked to cooperate with the recall process and immediately stop dispensing and supplying the affected batches.