Overview
- Digemid, which issued Alerta N.° 038-2026 on Monday, ordered the withdrawal and destruction of all units of Gentabiot 160 mg/2 mL lot 195230802.
- Indecopi publicized the order nationwide through its Consumer Alerts System and told hospitals, clinics, and pharmacies to check stock and stop using the flagged vials.
- The lot failed the visible‑particle test, a critical defect in injectables because particles can block blood vessels, trigger local reactions, or introduce germs.
- The product’s registration holder is Distribuidora Dany S.A.C., the manufacturer is Jiangsu Runian Qianjin Pharmaceutical Co. Ltd in China, and only this single lot is affected.
- Officials urged consumers and providers to verify the lot number, avoid any matching units, and report cases to Indecopi or Digemid, with no linked adverse events reported in the articles.