A nationwide recall has been issued for a batch of Aclon (Aceclofenac 100mg) film-coated tablets after tests revealed significant quality control failures. The Drug Administration of Vietnam announced the decision on 24/3, citing results from the Ho Chi Minh City Institute of Drug Control. Samples of the drug, bearing registration number VD-18521-13 and lot number ACT3003, failed to meet standards for dose uniformity, related impurities, water content, and assay. These violations are classified as level 2, indicating a potential risk to treatment efficacy and user safety. Manufactured by Shinpoong Daewoo Pharmaceutical Co. on 28/4/2023 with an expiry date of 27/4/2026, Aclon is prescribed for pain relief and anti-inflammation in conditions such as osteoarthritis and arthritis.

Following the findings, the Drug Administration of Vietnam has directed Shinpoong Daewoo Pharmaceutical Co. to immediately halt all sales, quarantine the entire remaining batch, and complete its recall within 15 days from the decision date. The company is also required to submit a detailed distribution report within 7 days and provide comprehensive recall results within 3 days of completion.

Shinpoong Daewoo Pharmaceutical Co. is responsible for all costs associated with the recall, drug disposal, and any compensation for damages, as stipulated by regulations. In parallel, pharmaceutical businesses, pharmacies, and medical examination and treatment facilities nationwide must immediately stop selling, dispensing, and using the affected batch, returning it to the supplier.

Local Departments of Health have been tasked with widely publicizing the recall decision, supervising its implementation, and penalizing non-compliant entities. The Dong Nai Department of Health bears specific responsibility for monitoring and evaluating the recall's effectiveness and assessing potential health risks to users.

Le Nga