The Drug Administration of Vietnam, operating under the Ministry of Health, has issued formal administrative sanctions against two pharmaceutical manufacturers for producing batches of musculoskeletal medications that failed to comply with state quality criteria. Each corporate entity was ordered to pay a statutory fine of 70 million VND, resulting in a cumulative penalty of 140 million VND. Alongside the financial liabilities, both enterprises are legally mandated to carry out the total destruction of the non-compliant product lots under regulatory supervision.
The technical profiles and batch specifications of the restricted medications identify the following targets:
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Shinpoong Daewoo Formulation: Aclon film-coated tablets, formulated with the active ingredient Aceclofenac 100mg. The implicated units belong to lot number ACT3003, manufactured on April 28, 2023, with an expiration matrix set for April 27, 2026.
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Stellapharm Formulation: Aceclofenac STELLA 100mg film-coated tablets (containing Aceclofenac 100mg), registered under marketing authorization number VD-20124-13. The non-compliant batch carries the lot identifier 070423, manufactured on April 7, 2023, and expiring on April 7, 2026.
Both pharmaceutical preparations utilize Aceclofenac as their primary active ingredient, a specialized compound routinely prescribed to mitigate pain and inflammation associated with arthritic diseases, such as osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis.
Prior to the enforcement of these fiscal penalties, the Ministry of Health had implemented a nationwide recall covering both drug batches after laboratory reference samples demonstrated a Class 2 regulatory violation due to non-compliance with permissible thresholds for related impurities. Furthermore, the Aclon batch produced by Shinpoong Daewoo exhibited multiple additive structural deficiencies, failing mandatory verification controls for asset quantification, moisture content boundaries, and dosage unit uniformity.
Under domestic health guidelines, Class 2 pharmaceutical violations are designated for products showing verified evidence of compromised therapeutic efficacy or potential safety hazards to consumers, though the level of non-compliance has not yet reached the threshold of causing severe systemic health destruction or immediate life-threatening outcomes.