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Taiwan recalls cancer drugs containing extraneous material

2021-01-20
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Taiwan recalls cancer drugs containing extraneous material
Taiwan recalls cancer drugs containing extraneous material

Taipei, Jan. 19 (CNA) A total of 9,000 cancer drugs manufactured by the Taiwanese company TTY Biopharm Company Limited are being recalled because they were found to contain extraneous material, Taiwan's Food and Drug Administration (FDA) said Tuesday.

The drugs include Gemmis injection 38 mg/ml, which is usually used in combination with other medicines such as Gemcitabine and paclitaxel to treat cancer of the lungs, pancreas, bladder and breast in specific cases, the FDA said.

The contamination of the 9,000 cancer drugs with extraneous material was discovered after a hospital reported such findings to the FDA in December 2020, said Hung Kuo-teng, head of the FDA's Medicinal Products Division.

The specific extraneous material has not yet been determined, but TTY Biopharm has been instructed to investigate and submit a report to the FDA, he said.

Meanwhile, the company must recall the 9,000 cancer drugs by Feb. 5, Hung said.

In a statement, TTY Biopharm said it has informed all hospitals and pharmacies about the issue and asked them to stop the use of the drugs, which will all be recalled by the end of the week.

Regarding the Gemmis injection, only batch number LTW2015 was found to contain extraneous material, the company said.

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