Vietnam: Suspension of circulation and recall of Estro Skin Roya product batch nationwide

Vietnam: Suspension of circulation and recall of Estro Skin Roya product batch nationwide (Internet image)

Vietnam: Suspension of circulation and recall of Estro Skin Roya product batch nationwide

According to Official Dispatch 2084/QLD-MP, based on Official Dispatch No. 92/TTKN-KHTH dated June 17, 2024, from the Quality Control Center - Quang Ninh Province Department of Health, accompanied by Testing Report No. 211TN dated June 17, 2024, and related documents reporting the Estro Skin Royal product batch, the label states: Batch No.: 10.08.23; Mfg Date: August 10, 2023; Exp Date: August 9, 2026; Certification No.: 3216/18/CBMP-HN; Company responsible for market distribution: Sao Hoang Gia Trading Joint Stock Company, Address: No. 24, Nguyen Thai Hoc Street, Dien Bien Ward, Ba Dinh District, Hanoi; Manufacturer: Rio Pharmacy Pharmaceutical Joint Venture Company Limited, Address: Km 24, Phu Nghia Industrial Park, Nghia Hao, Phu Nghia, Chuong My District, Hanoi.

The above cosmetic sample was taken by the Quality Control Center - Quang Ninh Province Department of Health from Thai Ngoc Trading Pharmaceutical Company Limited (Address: No. 3, Group 12, Zone 4, To Hien Thanh Street, Tran Hung Dao Ward, Ha Long City, Quang Ninh Province) for quality testing. The sample did not meet quality standards due to containing the preservative ingredients Methyl paraben and Propyl paraben, which were not listed in the product's certified formula.

* Drug Administration announce the following:

• Suspend the circulation and recall nationwide the batch of Estro Skin Royal, labeled: Batch No.: 10.08.23; Mfg Date: August 10, 2023; Exp Date: August 9, 2026; Certification No.: 3216/18/CBMP-HN; Company responsible for market distribution: Sao Hoang Gia Trading Joint Stock Company, Address: No. 24, Nguyen Thai Hoc Street, Dien Bien Ward, Ba Dinh District, Hanoi; Manufacturer: Rio Pharmacy Pharmaceutical Joint Venture Company Limited, Address: Km 24, National Highway 6, Nghia Hao Village, Phu Nghia Commune, Chuong My District, Hanoi.
• Reason for recall: The test sample did not meet quality standards due to containing preservative ingredients Methyl paraben and Propyl paraben, which were not listed in the product's certified formula.

* Request the Health Departments of provinces and centrally-managed cities to:

• Notify cosmetic business and usage establishments in their territories to immediately cease trading and using the above-mentioned batch of Estro Skin Royal and return it to the product supplier;

• Carry out the recall and destruction of the mentioned violating product batch; monitor the units to implement this announcement; handle violating units as per current regulations.

* Sao Hoang Gia Trading Joint Stock Company and Rio Pharmacy Pharmaceutical Joint Venture Company Limited must:

• Send recall notices to distributors and users of the above-mentioned batch of Estro Skin Royal; Accept returned products from business establishments and proceed with recalling and destroying the entire batch of non-compliant products.

• Submit a recall report of the above-mentioned batch of Estro Skin Royal to the Drug Administration before July 25, 2024.

* Request the Health Department of Hanoi to:

• Inspect Sao Hoang Gia Trading Joint Stock Company and Rio Pharmacy Pharmaceutical Joint Venture Company Limited for compliance with cosmetic management laws in their production and business activities.

• Supervise the companies in recalling and destroying the non-compliant Estro Skin Royal product batch; Handle and penalize violations according to current regulations, and report results to the Drug Administration before August 10, 2024.

Le Nguyen Anh Hao

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