Overview
- The INS confirmed Ralstonia pickettii in Edetoxin lot ABO25001, prompting national immobilization and the suspension of importer Nordic Pharmaceutical Company S.A.C.
- CDC Perú’s epidemiological alert AE–CDC N.º 006-2025 remains active and Digemid’s Health Alert No. 116-2025 instructs facilities to report cases and reinforce infection-control practices.
- Cases span six Lima facilities and involve critically ill or immunocompromised patients; the sedative’s active ingredient is dexmedetomidine used in ICU care, not for ambulatory dispensing.
- The Health Ministry referred the case to the Procuraduría for civil and criminal action, and Indecopi opened a preliminary probe that could lead to fines of up to 450 UIT and corrective measures.
- Edetoxin is manufactured in India by Farbe Firma PVT LTD, which lacks Peruvian GMP certification, and Digemid says an inspection mission to the plant in India is planned for mid-November.