The recalled batch, identified by lot number 0125 and registration number 893110447024, was manufactured by the Medical Pharmaceutical and Biological Joint Stock Company (Mebiphar) branch on 20/4/2025, with an expiry date of 20/4/2028. This recall decision stems from testing results by the Thanh Hoa Testing Center and the Ho Chi Minh City Institute of Drug Testing, which confirmed the drug sample had a level 3 violation due to failing quality requirements for water content.

The regulatory agency mandates that the manufacturer coordinate with distribution units to issue recall notices to all wholesale and retail establishments and users nationwide within 15 days. The company must bear all costs associated with the recall process, handling defective products, and compensating for damages in accordance with legal regulations. Additionally, medical facilities and the public are advised to immediately cease prescribing, distributing, or using this drug batch and return it to the supplier.

Poor control of water content in hard capsules directly impacts drug stability, potentially reducing treatment efficacy or altering drug properties during storage. Diacerin, a non-steroidal anti-inflammatory drug, is typically prescribed by doctors to relieve pain and improve mobility for patients suffering from hip or knee osteoarthritis.

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