Argentina’s medicines regulator, ANMAT, has prohibited the sale and distribution of a dermatology line linked to Caflab Applied Science after uncovering a lack of official registration and safety concerns, amid broader efforts to crack down on unregistered medical products.
Argentina’s medicines regulator has banned the sale, distribution and use nationwide of a skin-care and dermatology line linked to Caflab Applied Science after finding it lacked health authorisation, according to La Nación. The National Administration of Drugs, Food and Medical Technology, better known as ANMAT, said the products cannot return to the market until they are properly registered.
The action was triggered by a consumer complaint after a trichloroacetic acid product sold through Mercado Libre was found to be marketed for wart removal and other dermatological uses. Inspectors then found that the company’s website was offering other items, including Gram stain, Lugol solution, safranin, methylene blue and saline, and concluded that their therapeutic claims and presentation placed them in the category of medicines.
ANMAT said its checks showed that Laboratorio Caflab was not registered to make medicines, medical products, in vitro diagnostic items or cosmetics, and that the products under review had no official registration. The health ministry in Buenos Aires province also reported that it had no record of a pharmaceutical establishment under the name Caflab Applied Science, or of any authorisation for the address printed on the packaging. The agency said the manufacturing conditions and actual composition of the goods were unknown, creating a risk for users, and its legal department filed a criminal complaint over an alleged offence against public health.
In a separate ruling, ANMAT also barred the use, sale and distribution of specific Medtronic diabetes products after a theft was reported in Rosario in July. According to the filing by import company Implantes Quirúrgicos, the missing items included Paradigm reservoirs, MiniMed infusion sets and Guardian 4 sensors. The regulator said the units’ current condition could not be verified, so it imposed the ban to protect consumers and patients. This latest move fits a broader pattern this year, with ANMAT repeatedly acting against unregistered or irregular medical and cosmetic products.
Disclaimer: This content is for informational purposes only and is not intended to be a substitute for professional medical judgment, advice, diagnosis, or treatment.
