Anvisa Determina Recolhimento de Medicamentos Falsificados Keytruda e Saizen
Summary
ANVISA determined the seizure of two lots of falsified medications: Keytruda (pembrolizumabe), lot Y020844, and Saizen (somatropina), lot AB003660. The manufacturers Merck Sharp & Dohme Farmacêutica Ltda and Merck S/A informed ANVISA they do not recognize these lots as their products. The action was formalized under Resolução RE 1.683/2026, published April 24, 2026.
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GovPing monitors Brazil ANVISA for new healthcare & life sciences regulatory changes. Every update since tracking began is archived, classified, and available as free RSS or email alerts — 18 changes logged to date.
What changed
ANVISA issued Resolução RE 1.683/2026 ordering the seizure of two specific lots of falsified medications from the Brazilian market. Keytruda (pembrolizumabe), used in cancer treatment, lot Y020844, and Saizen (somatropina), a growth hormone, lot AB003660, have been confirmed as counterfeit by the original manufacturers. Healthcare providers, pharmacies, and distributors should immediately verify their inventory against these lot numbers and report any identified falsified products to ANVISA. Patients who may have received these medications should consult their healthcare providers for guidance.
The affected parties include all entities in the pharmaceutical supply chain that may hold these specific lots. This enforcement action underscores ANVISA's ongoing efforts to combat falsified medicines in Brazil, particularly high-value specialty drugs used in serious medical conditions.
What to do next
- Verify inventory for Keytruda lot Y020844 and Saizen lot AB003660
- Contact ANVISA if falsified lots are identified
Archived snapshot
Apr 27, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
PROIBIÇÃO
Anvisa determina recolhimento de medicamentos falsificados
Fabricantes informaram não reconhecer lotes de produtos disponíveis no mercado Compartilhe: Publicado em 27/04/2026 11h29 Atualizado em 27/04/2026 11h32 A Agência Nacional de Vigilância Sanitária (Anvisa) determinou a apreensão de lotes dos medicamentos Keytruda (pembrolizumabe), utilizado no tratamento de câncer, e Saizen (somatropina), hormônio de crescimento.
A Merck Sharp & Dohme Farmacêutica Ltda e a Merck S/A, fabricantes dos produtos, informou desconhecer os seguintes lotes:
Keytruda (Y020844)
Saizen (AB 003660)
Lei a Resolução (RE) 1.683/2026.
Categoria Saúde e Vigilância Sanitária
Tags: medicamento falsificado apreensão Compartilhe:
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