The Drug Administration of Vietnam, under the Ministry of Health, has mandated a comprehensive nationwide recall of a specific batch of Diacerin 50 hard capsules (Diacerein 50 mg). This directive follows official findings that the product failed to meet the necessary technical standards for pharmaceutical quality.
Details of the recalled batch:
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Brand name: Diacerin 50.
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Registration number: 893110447024.
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Batch number: 0125.
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Manufacturing date: April 20, 2025; Expiry date: April 20, 2028.
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Manufacturer: Branch of Medical Pharmaceutical and Biological Joint Stock Company.
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Reason for recall: Testing samples conducted in Thanh Hoa and Ho Chi Minh City revealed that the water content exceeded approved limits (level 3 violation).
Requirements for relevant entities:
Supply units and healthcare facilities must immediately cease the trade, prescription, and administration of the aforementioned batch. The manufacturer is responsible for coordinating with stakeholders to retrieve the products from consumers and distributors, while reporting the results to the Drug Administration and local Health Departments within the prescribed timeframe. The manufacturer will also be liable for recall costs and legal compensation.
In a related development, the Ministry of Health has released a list of 46 foreign pharmaceutical companies with a history of quality violations, requiring 100% inspection of all imported batches from these entities.
Source: https://suckhoedoisong.vn/bo-y-te-thu-hoi-toan-quoc-lo-thuoc-diacerin-50-169260124151738917.htm