Brasília – The National Health Surveillance Agency (Anvisa) has ordered the suspension and seizure of specific falsified batches of oncology drugs circulating in Brazil. The measure targets two lots of Keytruda (100 mg/4 ml) — SO48607 and Y019148 — and one lot of Avastin (H0386H05), identified as counterfeit after verification by the manufacturers. The distributor responsible for some of these products, LAF Med Distribuidora de Medicamentos e Materiais Hospitalares Ltda., had its operating licence revoked by Anvisa earlier this year.

According to the agency, the falsified medicines presented inconsistencies in labeling, barcodes and traceability data, indicating irregular origin and handling. The prohibition includes all activities related to these lots — storage, sale, distribution, advertising, transport and use — and extends to any other batches that show similar authenticity issues. Health services, pharmacies and hospitals were instructed to immediately check their inventories and report any suspected products to the sanitary surveillance authorities.

Anvisa emphasized that counterfeit medicines pose serious risks to patients, as their composition, concentration and safety cannot be guaranteed. The agency reaffirmed its commitment to strengthening the national drug-traceability system and tightening inspection of oncology drug distribution chains, especially for high-cost and imported treatments. The action highlights the importance of maintaining supply-chain integrity to ensure patient safety and public trust in cancer therapies.

Source: Anvisa

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