The 2 batch numbers of the kidney disease drug "Kuyu Cremetin Rapidly Disintegrating Tablets 500 mg" will be recalled before July 1. (Picture taken from the official website of the Food and Drug Administration)
[Reporter Luo Bi/Reporting from Taipei] The Food and Drug Administration announced drug recall information. The commonly used drug "Kuyu" Crimidin Rapidly Disintegrating Tablets 500 mg for patients with kidney disease (Ministry of Health Drug Transmission No. 028080) was due to residual solvents (B) in the manufacturing process. There was a deviation in the inspection method for alcohol), and a preventive recall was initiated. The affected batch numbers are TT24Y05 and TT24Z13, with a total of 1.38 million, 624 tablets sold. The Food and Drug Administration requires manufacturers to complete the recall operation before July 1.
The Food and Drug Administration stated that according to the drug license holder Xingchang Pharmaceutical Technology Co., Ltd., it took the initiative to report on May 28. The original manufacturer's notice pointed out that there was a deviation in the testing method for the residual solvent (ethanol) used in the manufacturing process of the drug in the case. Although it was confirmed that the relevant batches of products met the specifications and no relevant adverse event notifications had been received so far, based on drug quality and medication safety considerations, it was decided to initiate preventive recall measures.
According to an investigation by the Food and Drug Administration, the Japanese competent authority issued a recall warning in May, pointing out that some batch numbers of Cremetin fast-disintegrating tablets 500 mg produced by the Japanese pharmaceutical company KUREHA Corporation may be due to deviations in the inspection method, resulting in concerns that the residual solvent ethanol content exceeds the specification, so the recall was initiated. After an inventory, our country confirmed that 2 batches of imported products were affected, and on June 1, we sent a letter to the industry to request the industry to start recycling operations.
The Food and Drug Administration pointed out that the main ingredient of this drug is spherical absorptive carbon, and its indications are related symptoms caused by adsorption of bacterial toxins, digestive toxins and other organic wastes that interfere with the gastrointestinal tract. It is a drug instructed by a physician, pharmacist or pharmacist, and must be used under the advice of professionals.
Will it affect the supply of medicine? The Food and Drug Administration stated that it has learned from the industry that there are still other unaffected batch numbers available for supply to the market, and the inventory is sufficient, and imports will continue in the future, so there is no concern about drug shortage at the moment.
The Food and Drug Administration has required medical institutions, pharmacies and drug dealers to immediately remove the product from the shelves and cooperate with the recall. The operators must complete the recall operation before July 1 and submit investigation reports and preventive and corrective measures. If the recall is not carried out in accordance with the regulations, a fine of NT$200,000 to NT$5 million will be imposed in accordance with Article 91 of the Pharmaceutical Affairs Act.
The Food and Drug Administration reminds the public that if they hold drugs with affected batch numbers, they can contact the original medical institution or pharmacy. If a suspected adverse reaction occurs after use, they can also report it through the National Adverse Drug Reaction Reporting System to ensure drug safety.
The indications of Cremetin Rapidly Disintegrating Tablets 500 mg are related symptoms caused by adsorption of bacterial toxins, digestive toxins and other organic wastes that interfere with the gastrointestinal tract. (Picture taken from the official website of the Food and Drug Administration)
