The Federal Commission for the Protection against Health Risks (Cofepris) has issued an alert regarding the counterfeiting and illegal marketing of the Restylane Kysse medical device.
According to the statement, The product is used in aesthetic lip filler proceduresso the government agency argued that it sought to prevent diseases caused by the use of the counterfeit product.
The company that owns the health registry notified Cofepris about several anomalies that allow the identification of the counterfeit productincluding spelling errors, false originality seal and QR code, as well as discrepancies in the batch number and expiration date.
Cofepris recommendations to verify authenticity
In this situation, Cofepris recommends beauty clinics and other establishments verify the authenticity of the distributorensuring that it is authorized and validated by the manufacturer.
He indicated that it is important that the distributor has a health license and operating notice issued by Cofepris, as well as demonstrate the legality of the acquisition of the product.
The marketing of the counterfeit product fails to comply with health legislation, and Cofepris will impose sanctions that may include fines and temporary or permanent closures.
Therefore, Cofepris invites the community to report any quality problems or adverse incidents related to the use of Restylane Kysse or other medical devices in the Online Medical Device Adverse Incident Reporting System.
The institution remains vigilant against any risk to public health and works to guarantee the safety and effectiveness of medical products used in aesthetic procedures.
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