According to the decision on 5/8, the affected product is Promed Gel, in 30g tubes, batch number 010124. It is manufactured by Starmed High-Tech Pharmaceutical Joint Stock Company in Hung Yen and distributed by Starmed Pharmaceutical Group Joint Stock Company in Hanoi.
Test results from the Hanoi Center for Drug, Cosmetics, and Food Testing, taken from An Khanh Pharmacy (Hoang Mai), revealed the presence of methylparaben, which was not listed in the registered formula. Furthermore, the phenoxyethanol content was measured at 1.08%, exceeding the permitted limit of 1%.
The product's instructions also contained discrepancies with the product announcement and regulations, including claims like "scar prevention," and "skin cell regeneration, rapid wound healing," which are unsuitable for cosmetic products.
Methylparaben and phenoxyethanol are common preservatives in cosmetics, used to inhibit microbial growth. However, experts warn that exceeding permitted levels can cause allergic reactions, endocrine disruption, and long-term health issues, especially for sensitive individuals.
The US Food and Drug Administration (FDA) has warned that phenoxyethanol can cause nausea and diarrhea in infants and negatively impact the nervous system. In its pure form, this chemical has also been linked to reproductive and neurological problems.
The Drug Administration of Vietnam has ordered local Departments of Health to instruct businesses to immediately halt sales of the affected batch, return it to the supplier, and ensure its destruction. The Hanoi and Hung Yen Departments of Health will inspect the two companies involved for compliance with cosmetic production and trading regulations, imposing penalties for any violations.
The two companies are required to retrieve the returned product, destroy the substandard batch, and review other manufactured batches for similar issues. A recall report must be submitted to the Drug Administration of Vietnam by 14/8. Failure to provide an honest report will result in the companies bearing full legal responsibility.
Authorities have recently uncovered numerous violations at production and trading facilities, leading to the recall and destruction of counterfeit and substandard drugs and cosmetics. In June, the Drug Administration of Vietnam conducted surprise inspections of 38 facilities, finding 17 in violation. Simultaneously, 20 provinces and cities inspected 865 production, import, and trading facilities, uncovering violations at 48.
Le Nga
