The Food and Drug Administration (FDA) yesterday said it has ordered TTY Biopharm Co Ltd (台灣東洋藥品) to recall 9,000 vials of a cancer drug after they were found to have been contaminated by extraneous material.
The drug, Gemmis Injection, is sold in 38ml vials and is usually used in combination with other medicines, such as gemcitabine and paclitaxel, to treat cancer of the lungs, pancreas, bladder or breast in specific cases, the FDA said.
The FDA urged people using Gemmis not to stop using it on their own and to ask their doctor to prescribe alternate medication.
The contamination was discovered after a hospital notified the FDA last month, Medicinal Products Division head Hung Kuo-teng (洪國登) said.
The specific extraneous material has not yet been determined, but TTY Biopharm has been instructed to investigate the matter and submit a report to the FDA, he said.
The company must complete the recall by Feb. 5, Hung said.
TTY Biopharm in a statement said that it has informed all hospitals and pharmacies about the issue, and asked them to stop using the drug, adding that it would recall the medicine by the end of this week.
Only batch number LTW2015 was found to contain extraneous material, the company said.
It said it would continue to improve quality controls, process management and personnel training, and demonstrate a responsible attitude toward drug safety.
If the firm fails to complete the recall by the deadline, it could face a fine of up to NT$5 million (US$175,617) under the Pharmaceutical Affairs Act (藥事法).
POLAM KOPITIAM CASE: Of the two people still in hospital, one has undergone a liver transplant and is improving, while the other is being evaluated for a liver transplant A fourth person has died from bongkrek acid poisoning linked to the Polam Kopitiam (寶林茶室) restaurant in Taipei’s Far Eastern Sogo Xinyi A13 Department Store, the Ministry of Health and Welfare said yesterday, as two other people remain seriously ill in hospital. The first death was reported on March 24. The man had been 39 years old and had eaten at the restaurant on March 22. As more cases of suspected food poisoning involving people who had eaten at the restaurant were reported by hospitals on March 26, the ministry and the Taipei Department of Health launched an investigation. The Food and
The long-awaited Taichung aquarium is expected to open next year after more than a decade of development. The building in Cingshui District (清水) is to feature a large ocean aquarium on the first floor, coral display area on the second floor, a jellyfish tank and Dajia River (大甲溪) basin display on the third, a river estuary display and restaurant on the fourth, and a cafe and garden on the fifth. As it is near Wuci Fishing Port (梧棲漁港), many are expecting the opening of the aquarium to bring more tourism to the harbor. Speaking at the city council on Monday, Taichung City Councilor
A fourth person has died in a food poisoning outbreak linked to the Xinyi (信義) branch of Malaysian restaurant chain Polam Kopitiam (寶林茶室) in Taipei, Deputy Minister of Health and Welfare Victor Wang (王必勝) said on Monday. It was the second fatality in three days, after another was announced on Saturday. The 40-year-old woman experienced multiple organ failure in the early hours on Monday, and the family decided not to undergo emergency resuscitation, Wang said. She initially showed signs of improvement after seeking medical treatment for nausea, vomiting and diarrhea, but her condition worsened due to an infection, he said. Two others who
Taiwanese should be mindful when visiting China, as Beijing in July is likely to tighten the implementation of policies on national security following the introduction of two regulations, a researcher said on Saturday. China on Friday unveiled the regulations governing the law enforcement and judicial activities of national security agencies. They would help crack down on “illegal” and “criminal” activities that Beijing considers to be endangering national security, according to reports by China’s state media. The definition of what constitutes a national security threat in China is vague, Taiwan Thinktank researcher Wu Se-chih (吳瑟致) said. The two procedural regulations are to provide Chinese