Vietnam orders nationwide recall of substandard joint pain medication

The batch of Aceclofenac STELLA 100mg film-coated tablets bearing registration number VD-20124-13 and numbered 070423 was manufactured on April 7, 2023 by Stellapharm Joint Venture Company headquartered in Ho Chi Minh City, with an expiry date of April 7.

The batch was identified as having a level-two violation, meaning that the drug may not ensure full therapeutic effectiveness or could carry potential safety risks, though it is not considered likely to cause serious harm to health or life.

Under the recall order, Stellapharm is required to immediately halt distribution, and must also provide detailed reports on the drug’s distribution to wholesalers and healthcare facilities.

In addition, Stellapharm is responsible for notifying all relevant distributors, pharmacies, healthcare providers, and consumers who may have received the product.

The recall process must be completed within 15 days from the date of the order.

The firm will cover all costs associated with the recall and disposal of the defective drugs and is obligated to compensate for damages in accordance with Vietnamese law.

The handling and disposal of the recalled medication must comply with regulations issued by the Ministry of Health regarding quality control, testing, and recall procedures.

Stellapharm must submit a written report on the recall results to the Drug Administration of Vietnam and the Ho Chi Minh City Department of Health within three days of completing the process.

The administration has also instructed wholesalers, retailers, and pharmacy chains nationwide to immediately stop selling and distributing the affected batch and return it to the suppliers.

Healthcare providers and patients are advised to cease prescribing, dispensing, or using the recalled medication and return it to the point of purchase.

Provincial and municipal health departments have been tasked with disseminating information about the recall, publishing notices on their official websites, and monitoring compliance.

Any violation of the recall directive will be handled in accordance with current regulations.