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Spain Orders Withdrawal of Injected Cosmetic Products Containing Hyaluronidase

The Spanish medicines regulator has halted sales and mandated the recall of Proteos Biotech products marketed for unapproved injectable use.

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Overview

  • The Spanish Agency for Medicines and Medical Devices (AEMPS) has banned the commercialization of HA Corrector, Pbserum Enzymatic Solution, and Pbserum HA.
  • These products, classified as cosmetics, were improperly promoted for injection to address complications from hyaluronic acid fillers.
  • Hyaluronidase, an enzyme included in these products, is prohibited for use in cosmetics under Spanish law.
  • AEMPS has instructed the immediate market withdrawal and recovery of all affected units, citing unproven safety and efficacy for aesthetic purposes.
  • Consumers are advised not to use these products and to return them to the point of purchase or contact the manufacturer for further guidance.