Suspension of circulation and nationwide recall of Gammaphil product batch in Vietnam

Suspension of circulation and nationwide recall of Gammaphil product batch in Vietnam (Internet image)

Suspension of circulation and nationwide recall of Gammaphil product batch in Vietnam

According to Official Dispatch 1477/QLD-MP in 2024:

Based on Official Dispatch 19/BC-TTKN dated May 7, 2024, from the Yen Bai Center for Drug, Cosmetics, and Food Testing, along with test report 24L-025MP dated May 6, 2024, and related documents regarding the batch of Gammaphil product - 125ml bottle, with label information: Batch number: GMDK010124; Manufacturing date: January 2, 2024; Expiry date: January 2, 2027; Announcement number: 000669/21/CBMP-HCM; Manufactured and responsible for bringing the product to market: GAM MA cosmetic production company, office address: 18 Nguyen Hau Street, Tan Thanh Ward, Tan Phu District, Ho Chi Minh City, production facility address: Group 1, Phu Hiep Hamlet, Phu Hoa Dong Commune, Cu Chi District, Ho Chi Minh City.

The cosmetic sample was taken by the Yen Bai Center for Drug, Cosmetics, and Food Testing at Son Thuy Pharmaceutical Co., Ltd. (Address: 509 Yen Ninh Street, Group 8, Yen Ninh Ward, Yen Bai City, Yen Bai Province) for quality testing. The sample did not meet quality standards due to the presence of preservatives Methyl paraben and Propyl paraben, which are not listed in the product's formula as stated in the product announcement receipt.

Therefore, the Drug Administration off Vietnam announces the following:

- Suspending circulation and nationwide recall of the Gammaphil product batch - 125ml bottle, with label information: Batch number: GMDK010124; Manufacturing date: January 2, 2024; Expiry date: January 2, 2027; Announcement number: 000669/21/CBMP-HCM; Manufactured and responsible for bringing the product to market: GAM MA cosmetic production company, office address: 18 Nguyen Hau Street, Tan Thanh Ward, Tan Phu District, Ho Chi Minh City, production facility address: Group 1, Phu Hiep Hamlet, Phu Hoa Dong Commune, Cu Chi District, Ho Chi Minh City.

Reason for recall: The tested sample did not meet quality standards due to the presence of preservatives Methyl paraben and Propyl paraben, which are not listed in the product's formula as stated in the product announcement receipt.

Departments of Health of provinces and centrally-run cities shall:

- Notify businesses and users within their jurisdiction to immediately cease trading and using the Gammaphil product batch - 125ml bottle mentioned above, and return the products to the supplying facility.

- Proceed with the recall and disposal of the non-compliant batch; inspect and supervise the implementation of this announcement; and handle violations according to current regulations.

GAMMA Pharmaceutical Manufacturing and Trading Co., Ltd. must:

- Send recall notices to distribution points and users of the Gammaphil product batch - 125ml bottle mentioned above; Receive returned products from businesses and proceed with the recall and disposal of the entire non-compliant batch.

- Submit a recall report for the Gammaphil product batch - 125ml bottle mentioned above to the Drug Administration before June 20, 2024.

Requesting the Ho Chi Minh City Department of Health to:

- Inspect GAMMA Pharmaceutical Manufacturing and Trading Co., Ltd. for compliance with cosmetic management regulations in their production and business activities.

- Monitor companies that carry out the recall and disposal of the Gammaphil product batch - 125ml bottle that does not meet the regulations.

- Take appropriate actions and penalties for violations according to current regulations and report the results to the Drug Administration of Vietnam before July 5, 2024.

Le Nguyen Anh Hao

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