Vietnam recalls children’s gel over undeclared preservative, unapproved medical claims

The recalled batch No. 010124, containing 30g tubes of Promed Gel manufactured on January 8, 2024 and expiring January 8, 2027, was found to contain methylparaben, a preservative not listed in the registered formulation, and phenoxyethanol at 1.08 percent, exceeding the limit set by the ASEAN Cosmetics Directive.

DAV also said the product’s packaging included unapproved claims such as 'scar prevention,' 'wound healing,' and treatment indications for viral skin diseases including hand, foot, and mouth, herpes, chickenpox, and measles — content not permitted under cosmetic regulations.

The gel was produced by Starmed High-Tech Pharmaceutical JSC in Hung Yen Province and distributed by Starmed Pharmaceutical Group JSC, based in Hanoi.

DAV instructed local health departments to halt distribution and usage of the affected batch, ensure the product is recalled and destroyed, and take action against any regulatory violations.

Both companies were ordered to notify distributors, collect all remaining stock, and submit a recall report to DAV by August 29.

They must also review other Promed Gel batches for similar issues and initiate recalls if necessary.

DAV warned that any false reporting would result in full legal accountability.

It also requested health authorities in Hanoi and Hung Yen to revoke the product registration and inspect the companies’ compliance with cosmetic production laws.