Overview
- Health officials report 28 confirmed infections linked to the Edetoxin lot ABO25001 used in hospital settings, with three deaths reported in the outbreak context and no established causal link to the drug.
- The Ministry of Health says the affected sedative, used only in intensive care, was fully immobilized and 99.8% of the 24,000 ampoules were recovered after quality tests detected sterility failures.
- Indecopi opened a preliminary investigation into importer Nordic Pharmaceutical Company S.A.C., the product’s sanitary registration was suspended, and the importer was temporarily closed as 64 related registrations are reviewed.
- Minsa states the contamination occurred during manufacture by Farbe Firma in India and is preparing a technical inspection mission to that site in mid-November as it intensifies oversight of foreign labs.
- Professional bodies including the Medical College of Peru urge repeal of the rule accepting foreign GMP certificates and call for immediate implementation of Peru’s ANM-issued certification, noting hundreds of foreign labs lack it.