Wed, Aug 09, 2023 page2

• Cherries from US, Canada fail inspections

  POSSIBLE SOLUTION: The FDA has recommended that the American Institute in Taiwan apply for a maximum residue limit for mefentrifluconazole on cherries

  • By Lee I-chia / Staff reporter
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  The Food and Drug Administration (FDA) yesterday released a list of 14 items that failed border inspections, including 18 batches of cherries from the US that failed border inspections in the past six months.

  The 14 items included cherries from the US and Canada, truffles from Italy, chanterelle mushrooms from France, honeydew melon from Japan, cumin from China, black sesame from China, cookies from Vietnam, cardamom from India, banana paste from the Philippines and training chopsticks from China.

  They failed the inspections for having excessive residue levels of pesticides, heavy metals, radioactive substances or acetic acid, and they have been returned or disposed of, the FDA said.

  

  Cherries from the US that failed the Food and Drug Administration’s border inspection are pictured in an undated photograph.

  Photo copied by Wu Liang-yi, Taipei Times

  Five items were fresh cherries — four from the US and one from Canada, the FDA said, adding that the four batches (a total of 14,160kg) from the US were found to have excessive residues of the fungicide mefentrifluconazole, while the batch (250kg) from Canada was found to have residues of the insecticide cyclaniliprole, which is banned in Taiwan.

  FDA Deputy Director Lin Chin-fu (林金富) said that a total of 18 batches of cherries imported from the US have failed the border inspection for excessive mefentrifluconazole residue and therefore the sampling rate has been tightened to 100 percent.

  Mefentrifluconazole can only be used on cucumbers and as Taiwan does not grow cherries, there is no maximum residue limit set for it on cherries, so if the residue concentration exceeds the limit of detection — 0.01 parts per million or more — it would fail the inspection, Lin said.

  

  Taiwan Biotech Co’s 0.2mg Holigin S.R. Capsules are pictured in an undated photograph.

  Photo courtesy of the Food and Drug Administration

  Lin said the FDA has informed the American Institute in Taiwan about the situation, and recommended that it submit information and apply for a maximum residue limit for mefentrifluconazole on imported cherries so that the government could draft new regulations.

  As a batch of Canadian cherries imported last year by the same importer had failed an inspection, the sampling rate was increased, he said, adding that it would be further tightened to batch-by-batch inspections until five consecutive batches pass the inspection.

  Meanwhile, the FDA also issued a recall on a drug used to treat benign prostatic hyperplasia — 0.2mg Holigin S.R. Capsules manufactured by Taiwan Biotech Co Ltd (信東生技) — whose main active ingredient is tamsulosin hydrochloride.

  FDA Deputy Director Chen Hwei-fang (陳惠芳) said 12 batches, about 1.7 million capsules, are being recalled as the drug has a two-year expiration date, but the company’s stability testing in the 18th month found that the dissolution performance had dropped to nearly the lowest specification limit, implying that its therapeutic effectiveness would fall below the specification before the expiration date.

  The FDA said it has asked the drug company to finish recalling the drug by Aug. 24, and it also informed healthcare facilities and pharmacies to stop prescribing the drug from the 12 batches and assist in recalling the drug.

  If people have concerns about the drugs they are taking they are advised to consult a doctor, it said.
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