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).
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