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WHO Orders Withdrawal of Six Contaminated Fentanyl Lots From Argentina

The notice cites severe manufacturing breaches at Ramallo/HLB, warning that post‑February 2022 injectables may be unsafe or already in other markets.

Overview

  • WHO Alert 4/2025 identifies six Fentanilo HLB injectable lots contaminated with multidrug‑resistant Klebsiella pneumoniae and Ralstonia pickettii, after an initial link to lot 31202.
  • Argentina’s regulator suspended Laboratorios Ramallo in February and in May banned all HLB Pharma products, with WHO urging continued vigilance because doses may still be in circulation.
  • Regulatory actions broadened as INAME/ANMAT inhibited Rigecin and Rivero within the past four days and ordered market withdrawals for hospital solutions over suspected contamination.
  • Investigators report at least 96 deaths linked to the outbreak, while courts review 122 clinical records as potential cases in the federal probe.
  • HLB/Ramallo owner Ariel García Furfaro remains detained as indagatorias continue this week, and WHO asks health systems to strengthen supply‑chain surveillance and report detections immediately.