Nationwide recall of Promed gel for antiseptic and scar prevention for children due to violations of ingredients and labels

Specifically, the Promed Gel product batch, box of 1 tube of 30g, has cosmetic product declaration receipt number (PCB) 52/22/CBMP-HY, production batch number 010124, production date 8-1-2024, expiration date 8-1-2027.

This product is manufactured by Starmed High-Tech Pharmaceutical Joint Stock Company (address: Xuan Dao village, Xuan Duc commune, My Hao town, former Hung Yen province) and Starmed Pharmaceutical Group Joint Stock Company (address: C12, TT6 Van Quan urban area, Hanoi city) is responsible for bringing it to the market.

Accordingly, the product batch had 3 violations. Test results showed that the Promed Gel sample contained methylparaben, a preservative that was not included in the published product formula.

In addition, the phenoxyethanol content in the product is 1.08%, exceeding the permissible limit as prescribed in Annex VI of the ASEAN Cosmetics Agreement.

Not only were the ingredients incorrect, the product was also found to have incorrect labeling. Specifically, the instructions printed on the packaging mentioned uses such as "preventing scars", "regenerating new skin cells, healing wounds quickly", or indicated for many skin diseases caused by viruses such as hand, foot and mouth disease, herpes, shingles, chickenpox, measles... while according to regulations, cosmetic products are not allowed to include content related to disease treatment.

These phrases seriously violate Circular No. 06/2011/TT-BYT and are inconsistent with the content of the issued declaration form.

The Drug Administration of Vietnam requests the health departments of provinces and cities to notify all businesses and cosmetic users in the area to immediately stop circulating and using the violating Promed Gel batch and return it to the supplier.

At the same time, organize the recall and destruction of all products, inspect and supervise the implementation and strictly handle violators according to the law.

Regarding the two companies involved, the department requested to send recall notices to the entire distribution system, facilities using, receiving and destroying all violating products.

Send the recall report to the Drug Administration before August 29. At the same time, review all other batches of Promed Gel products that have been produced. If similar errors are found, they must be recalled immediately.

The Department emphasized that if the reports are dishonest, the enterprise will take full responsibility before the law.

Along with the request to recall the product, the Drug Administration also requested the Hanoi and Hung Yen Departments of Health to withdraw the cosmetic product declaration receipt number 52/22/CBMP-HY, and at the same time inspect the compliance with legal regulations in the production and trading of cosmetics of the two Starmed companies mentioned above. In case of detecting violations, they must be handled according to regulations.