Mandatory recall of Diclofen drug batch due to quality violations.

The Drug Administration Department (Ministry of Health) has ordered a nationwide recall of Pharmedic's batch of Diclofenac 50 mg due to substandard quality, instructing all units to cease use and urgently organize the recall.

The Drug Administration of Vietnam announces the nationwide recall of the batch of Diclofen enteric-coated tablets (Diclofenac sodium 50 mg), Registration Number: VD-25150-16, Batch number 0040724, manufactured on July 26, 2024, expiry date July 26, 2027, produced by Pharmedic Pharmaceutical and Medicinal Materials Joint Stock Company.

Diclofenac is an anti-inflammatory and analgesic drug belonging to the NSAID group, widely used in the treatment of musculoskeletal disorders. The discovery of a substandard batch of the drug is a serious issue, potentially directly affecting treatment efficacy and patient safety if continued use occurs.

The Drug Administration of Vietnam has requested Pharmedic Pharmaceutical and Medicinal Materials Joint Stock Company to cease trading and quarantine all remaining recalled batches of drugs at its facility. A report on the distribution of the drugs to wholesale and medical examination and treatment facilities must be submitted to the Drug Administration of Vietnam and the Ho Chi Minh City Department of Health within 7 days.

Simultaneously, coordinate with relevant units to notify all wholesalers, retailers, pharmacy chains, medical facilities, and users who have received the medication about the recall.

The organization is responsible for recalling and receiving the entire batch of medicine within 15 days from the date of issuance of the decision. The batch of medicine will be processed according to regulations; costs for recall, processing, and compensation for damages will be paid in accordance with the law. The processing will be carried out in accordance with Circular 30/2025/TT-BYT.

Responsibilities of the relevant units:

Wholesale and retail establishments, and pharmacy chains: cease business operations, dispensing, and organize the recall of the drug batch.

Healthcare facilities and drug users: cease prescribing, dispensing, and using the medication; return the medication to the supplier.

Ho Chi Minh City Department of Health: inspecting and supervising Pharmedic Pharmaceutical and Medicinal Products Joint Stock Company during the recall and handling process.

Provincial and city health departments: notify drug-using facilities, publish recall information on their websites, and monitor and handle violations.

suckhoe.vtv.vn

Source: https://baolaocai.vn/thu-hoi-bat-buoc-lo-thuoc-diclofen-vi-pham-chat-luong-post888865.html