Argentina: Bacteria tainted fentanyl kills nine in Buenos Aires province
The National Administration of Drugs, Food, and Medical Technology (ANMAT) alerted the country's health centers last week about a batch of fentanyl ampoules associated with an outbreak of pneumonia that occurred in the intensive care unit of a private center in La Plata.
An outbreak of serious invasive infections associated with the use of contaminated fentanyl has caused nine deaths so far.
The product had been manufactured at a plant in the town of Ramallo, in the province of Buenos Aires, in a laboratory that had already faced successive marketing bans.
This outbreak affected 18 patients, all of whom had received a dose of the painkiller from the same batch.
According to reports, the bacteria Ralstonia pickettii and Klebsiella pneumoniae, producers of metallo-beta-lactamase (MBL), were detected in the contaminated vials, both in samples taken in La Plata and Rosario, Santa Fe, for two other detected cases.
All of the affected patients in the province of Buenos Aires were hospitalized in the intensive care unit of the Italian Hospital in La Plata and presented fever, due to the bacteria in their blood, and hypotension. Half died of septic shock caused by the infection.
The infected patients' symptoms appeared after receiving intravenous doses of ampules from lot 31202 of the opioid marketed by HLB Pharma. These ampules were manufactured on December 12, 2024, and expired on September 29, 2026.
As a result of the outbreak, the regulatory body ordered the prohibition of the laboratory HLB Pharma Group, responsible for marketing the ampules, and of Laboratorios Ramallo, which produced unauthorized products for HLB at its plant.
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Following the deaths of those affected, regulations prohibiting "the use, distribution, and marketing of all products registered in the name of HLB Pharma" throughout the country were published in the Official Gazette on May 13. The laboratory, located in the Buenos Aires town of San Isidro, remains closed.
The regulatory agency indicated that "the facts demonstrate that these were contaminated products manufactured in a facility with deficiencies in compliance with good practices, and therefore, it cannot be assured that the manufactured products comply, in a uniform and controlled manner, with the safety and efficacy requirements in accordance with the quality standards appropriate for their intended use." Following the detection of bacterial outbreaks in products and patient deaths, through Regulation 3158/2025, published in the Official Gazette, ANMAT ordered the virtual closure of HLB Pharma, halting the production of medicines and other medical supplies from the pharmaceutical company and its manufacturer, Laboratorios Ramallo SA.