The regulatory agency determined that the company's Padobaby powder, lot 110224, manufactured on 21/2/2024 and with an expiration date of 20/2/2027, violated quality standards at level 3. Each 3 g sachet of the medicine contains chlorpheniramine maleate 2 mg and paracetamol 325 mg.

For this violation, Medipharco was fined 50 million VND. The company was not subject to additional penalties, nor were there any aggravating or mitigating circumstances.

The company is responsible for paying the fine within 10 days of receiving the decision. If the company fails to comply voluntarily after this period, it will face enforced execution according to legal regulations and will incur an additional daily late fee of 0,05% calculated on the total overdue amount.

This specific drug lot was recalled three months prior by the Drug Administration after samples, collected and tested by the Central Institute of Drug Testing and the Ho Chi Minh City Institute of Drug Testing, revealed that the medicine failed to meet quality standards for methylparaben quantitative analysis. Methylparaben is a preservative commonly found in medicines and cosmetics. According to regulations, medicine that fails to meet quality standards for methylparaben quantitative analysis is classified as a level 3 violation and must be recalled.

Padobaby is a 3 g powdered oral medicine containing active ingredients: paracetamol (325 mg) and chlorpheniramine maleate (2 mg). It is commonly used for pain relief, fever reduction, and treating symptoms of the flu and allergies in children aged two and above, as well as adults.

Le Nga