Nationwide recall of Promed gel for acne and scar prevention

The Drug Administration has just announced the suspension of circulation and nationwide recall of a batch of Promed Gel products, box of 1 tube of 30 grams, due to instructions for use not being suitable for cosmetic products.

The Drug Administration of Vietnam ( Ministry of Health ) has just announced the suspension of circulation and nationwide recall of the cosmetic product batch Gel Promed, box of 1 tube of 30 grams; batch number 010124; Manufacturing date 8.1.2024; Expiry date: 8.1.2027; PCB reception number 52/22/CBMP-HY.

The product batch was recalled because the test sample contained methylparaben, which is not included in the product formula ingredients that have been granted a cosmetic product declaration receipt number; the phenoxyethanol content in the test sample was 1.08%, exceeding the allowable limit of 1%.

Nationwide recall of Promed Gel cosmetics batch with instructions for use inconsistent with the announcement

PHOTO: DAV.GOV.VN

The product's label and instructions for use contain content that is inconsistent with the declaration form and contain phrases that are inappropriate for cosmetic products such as: "prevent scarring"; "regenerate new skin cells, heal wounds quickly"; "target users: skin diseases caused by viral infections: hand, foot and mouth disease, herpes, chickenpox (chickenpox, blisters), shingles, measles; small wounds on the skin surface, cuts, small skin tears with little bleeding, blistering; mild to moderate burns; acne; dermatitis, folliculitis, ulcers, blisters; insect bites, mosquito bites".

The above product batch is responsible for bringing to market by Starmed Pharmaceutical Group Joint Stock Company ( Hanoi City); Starmed High-Tech Pharmaceutical Joint Stock Company (located in Hung Yen) is produced.

Immediately stop selling the violating product batch.

The Drug Administration requires Starmed Pharmaceutical Group Joint Stock Company and Starmed High-Tech Pharmaceutical Joint Stock Company to: recall and destroy product batches that do not meet regulations; review the production and labeling, instructions for use of other batches of the violating product that have been produced, and report the review and recall of the product to the Drug Administration before August 14.

The company is fully responsible before the law if the report is not truthful.

The Drug Administration of Vietnam requests the Hanoi Department of Health and the Hung Yen Department of Health to supervise Starmed Pharmaceutical Group Joint Stock Company and Starmed High-Tech Pharmaceutical Joint Stock Company in recalling and destroying the above-mentioned product batch; and recalling the cosmetic product declaration receipt number 52/22/CBMP-HY.

The Department also requested the health departments of provinces and cities to immediately stop trading and using the above violating batch of Promed Gel products. The health departments of provinces and cities notify the establishments that trade and use cosmetics in the area to immediately stop trading and using and return the products to the suppliers; recall and destroy the violating batch of products.

Source: https://thanhnien.vn/thu-hoi-toan-quoc-gel-promed-boi-mun-trung-ca-ngua-seo-185250805105952481.htm