According to the disciplinary decision announced on 24/5, Stellapharm Joint Venture Co., Ltd. (Ho Chi Minh City) was fined 70 million VND for manufacturing Aceclofenac STELLA 100 mg film-coated tablets, lot number 070423, which had a level 2 quality violation. The manufacturer released this batch on 7/4/2023, with an expiration date of 7/4.

Similarly, the administration imposed a 70 million VND fine on Shinpoong Daewoo (Dong Nai) for violations found in a batch of Aclon (Aceclofenac 100 mg) medication, lot number ACT3003. This batch, with registration number VD-18521-13, was produced on 28/4/2023 and expires on 27/4.

The regulatory body mandated that both companies immediately recall and destroy all affected drug batches, covering all associated destruction costs themselves.

Aceclofenac is an anti-inflammatory and pain-relieving active ingredient commonly used to treat musculoskeletal diseases. A "level 2 quality violation" indicates a potential impact on treatment effectiveness or drug safety, though it does not yet pose a serious threat to a patient's life. In contrast, a level one violation involves drugs that risk severe health harm or life-threatening danger to users, such as counterfeit drugs, drugs containing incorrect active ingredients, or contaminated injectable drugs.

This action aligns with the regulatory body's increased efforts to tighten control over the pharmaceutical and cosmetic markets. These measures aim to combat counterfeit and substandard products, as well as false advertising. Since the beginning of the year, the Ministry of Health has repeatedly ordered the suspension and destruction of many non-compliant products, most recently two types of sunscreen and facial masks due to incorrect manufacturing formulas.

Le Nga