Overview
- Sterility testing linked Ralstonia pickettii to Edetoxin lot ABO25001, prompting Digemid’s Health Alert No. 116-2025 and inactivation of the batch.
- Minsa immobilized 100% of the affected lot and reports 99.9% of vials recovered, noting the sedative is for ICU use and not sold in retail pharmacies.
- Authorities have confirmed 28 infection cases across hospitals, a clinic, and a dialysis center, including 13 at INSN San Borja, with continued surveillance and low community risk.
- A wider review identified 239 products tied to GMP failures; 57 registrations were suspended on Oct. 30 and about 50 more are set for suspension on Nov. 3.
- The importer Nordic Pharmaceutical Company S.A.C. was temporarily closed, Vice Minister Ricardo Peña Sánchez resigned, and legal actions are under evaluation as Digemid adds inspectors and an autonomy bill awaits Congress.