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Peru’s Drug Regulator Orders Recall and Destruction of Two Medicine Lots Over Safety Failures

The move follows lab failures that point to gaps in quality control across imported drugs.

Overview

  • Digemid ordered the immediate withdrawal and disposal of one Duoclamox lot and one Nitropruchyk lot after official tests found serious defects.
  • Duoclamox 500 mg tablets in lot Z23-969 failed the clavulanic acid content test, which could weaken treatment for common infections.
  • Nitropruchyk 50 mg injectable in lot 2124391A showed visible particles during safety checks, which can cause harm when given intravenously.
  • Indecopi issued public alerts through its Consumer Alert System, urged people to stop using affected units, and shared the Digemid hotline at (01) 631-4300 for guidance or reports.
  • Notices identify Zee Laboratories Ltd and Swiss Parenterals Ltd as the manufacturers and name Droguería Diphasac S.A.C. and Corporación H & K Pharma S.A.C. in Peru, with no confirmed clusters of adverse events or broad shortages reported so far.