Domestically produced drugs are in trouble again, “Shida” 6 drugs are unqualified and must be withdrawn from the market. Food and Drug Stop Kanlist-Free Health Net

[Reportero Wu Liangyi / Taipei Report]Drugs from Taiwan Pharmaceutical Factory are in trouble again! The Food and Drug Administration issued a drug recall message. Six drugs from the pharmaceutical factory “Star” did not pass the continuous stability test and must be removed from the shelves for recall. This is also the second time in a month that the drug has a problem. Recycling event.

Medications to be recalled by “Star” include “Tri-Zyme Powder” SD “,” Tri-Zyme Tablets “SD”, “TOS-PIDINE TABLETS” SD “,” Shu Amlopine Tablets 5 mg “SD” , “TALKAN CAPSULES” SD “,” LI SHIH “SD” TABLETS “.

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The Food and Drug Administration noted that the content of the main ingredients in these drugs has fallen below the quality standard, which may affect the effectiveness of drugs, so the pharmaceutical factory must recall all batches of drugs.

The Food and Drug Administration conducted inspections of China’s GMP pharmaceutical factories from June to July. The Jian Ren Jizheng Chen Yinghua quality supervision and management team said that during the factory inspection, Sida was found to remanufacture drugs with abnormal manufacturing processes and found some inspection data of drug component content. There are problems and they cannot be explained, so the pharmaceutical factory must investigate.

Chen Yinghua said that Star Pharmaceuticals reported that the content test results of the continuous stability test of six drugs did not meet the specifications, and that the effective ingredients of the drugs within the validity period would be less than 90%.

The indications for these drugs include the treatment of diarrhea, chronic liver disease, high blood pressure, cough, digestion, etc. All of them must be recycled without lot numbers.

In addition, there is also a “Dafeng Shumin Film-Coated Tablets 180mg” produced by “Dafeng Pharmaceutical” to alleviate allergic symptoms. The dissolution test results were also found to be out of specification. The lot number (9253201) must be recycled. .

Chen Yinghua said that for the violation of GMP, the Health Bureau will impose a fine of 30,000 to 2 million yuan according to the law. If the collection is not completed within the time limit, it will be fined 200,000 to 5 million yuan according to the law.

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