Recall and destroy RAILEZA products that do not meet quality standards

The Hanoi Department of Health has issued a notice to the health departments of districts, towns, and businesses and cosmetics users in the city about the suspension of circulation and recall of RAILEZA products that do not meet quality standards.

RAILEZA product - box of 1 bottle of 120ml, Receipt number of Declaration: 94/22/CBMP-HY; Batch number: 062024; Manufacturing date: March 18, 2024; Expiry date: March 17, 2027, Oceanpharma Joint Stock Company (address: Lot 45-LK1, An Hung Urban Area, Duong Noi Ward, Ha Dong District, Hanoi City) is responsible for bringing the product to the market and the manufacturer is Quang Xanh Pharmaceutical and Cosmetic Company Limited (address: Hanh Lac Village, Nhu Quynh Town, Van Lam District, Hung Yen Province).

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The reason is that the test sample does not meet the quality requirements for the microbial limit index in cosmetics as prescribed; the product is not classified as a cosmetic product.

Previously, the Department of Drug Administration, Ministry of Health issued document 3188/QLD-MP dated September 26, 2024 announcing the suspension of circulation, recall and destruction nationwide of the above RAILEZA product.

In the document of the Ministry of Health, it is stated that the sample of RAILEZA product was taken by the Center for Drug, Cosmetic and Food Testing, Department of Health of Thua Thien Hue province at Long Chau 468 pharmacy (address: 198 Nguyen Trai, Tay Loc ward, Hue city, Thua Thien Hue province) for quality testing and the test results showed that the sample did not meet the quality standards for the limit of microorganisms in cosmetics according to regulations.

According to the Declaration Form: 94/22/CBMP-HY issued by the Department of Health of Hung Yen province for the product RAILEZA, the declared product formula ingredients include "Sodium chloride, Sodium carboxymethyl cellulose, Permethrin 1%, Vitamin E, Propan 1,2,3-triol sodium ether monolauryl sulfate, Coco betaine, Oleic acid, Polyquatenium 10, Glycerine, Sodium benzoate, Tetra sodium ETDA, Purified water".

On the RAILEZA product label, it states: “Permethrin 1%”, “Target users: People with itching, lice, scabies, skin parasites”. Permethrin, CAS registration number No: 52645-53-1 (Chemical name: (±)-3- phenoxybenzyl 3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate) is used as an insecticide, belonging to the Pyrethroid family of drugs on the list of essential medicines of the World Health Organization (WHO), classified as an insecticide (ATC code: P03AC04).

Pursuant to the regulations on classification of cosmetic products in Circular No. 06/2011/TT-BYT dated January 25, 2011 of the Ministry of Health regulating the management of cosmetics and the ASEAN Cosmetic Harmonization Agreement, the above RAILEZA product is not classified as a cosmetic product.

Therefore, the Hanoi Department of Health announces and requests that cosmetic businesses and users in the area urgently review and immediately stop trading and using the above products.

For the health departments of districts, towns, the Department of Health requests to notify businesses and cosmetic users in the area to recall all the above products; inspect and supervise the recall implementation of the establishments.

Previously, regarding the management of cosmetic products, the Ministry of Health issued Directive Document No. 3873/BYT-VPB on this issue, stating that through information from the press, recently, a number of cases related to the detection and handling by authorities of a number of establishments producing and trading in counterfeit cosmetic products and cosmetics of unknown origin that were bought and sold on social networking sites, causing confusion among consumers.

To overcome the above situation, the Ministry of Health has assigned tasks to the Department of Drug Administration, the Ministry of Health Inspectorate and the Department of Health of provinces and cities.

The Ministry of Health requests the Department of Health of provinces and cities to strictly implement administrative procedures on granting acceptance numbers for domestically produced cosmetic product declaration forms; granting certificates of eligibility for cosmetic production; and re-issuing certificates of eligibility for cosmetic production to ensure timeliness and avoid causing inconvenience to businesses.

Strengthen inspection, examination and post-inspection of the implementation of regulations by enterprises in the process of production and distribution of cosmetic products, focusing on the issue of origin and advertising information.

Actively coordinate with local market management agencies to inspect and promptly detect cases of production and trading of fake cosmetic products, counterfeit brands or false advertising, exceeding the scope of published uses, and strictly handle violations.

Source: https://baodautu.vn/thu-hoi-va-tieu-huy-san-pham-raileza-khong-dam-bao-chat-luong-d226368.html