The Drug Administration of Vietnam (DAV) previously withdrew a batch of Aclon film-coated tablets, containing the same active ingredient Aceclofenac 100 mg, from the market last week for similar reasons.
The recalled Aceclofenac STELLA 100 mg batch has registration number VD-20124-13 and lot number 070423. It was manufactured on 7/4/2023 and expires on 7/4. The Ho Chi Minh City Institute of Drug Control conducted sample testing and found the product failed to meet relevant impurity standards.
The regulatory agency instructed Stellapharm to immediately cease trading the defective batch. Stellapharm must complete the recall process within 15 days and submit a detailed report. The manufacturer is responsible for all costs associated with the recall, disposal, and any potential damages.
Additionally, the DAV urged hospitals, pharmacies, and the public to immediately stop prescribing, selling, or using the product and to promptly return it to their suppliers. Provincial and city Departments of Health are tasked with widely disseminating this information, closely overseeing the product withdrawal, and strictly penalizing any deliberate violations.
Aceclofenac 100 mg is a non-steroidal anti-inflammatory drug (NSAID). Physicians commonly prescribe it to relieve pain and inflammation in patients suffering from rheumatoid arthritis or ankylosing spondylitis.
Le Nga
