What are the fentanyl ampoules and how was the medication contaminated?
Fentanyl is a high-potency opioid analgesic used in anesthesia and for the treatment of severe pain in hospitals. The ampoules involved were manufactured by HLB Pharma Group S.A. and produced in facilities of Laboratorio Ramallo S.A.
Official investigations revealed that they contained Klebsiella pneumoniae and Ralstonia pickettii, bacteria that can cause severe infections resistant to multiple antibiotics. The contamination, according to investigators, likely occurred during the manufacturing or packaging process.
The problem was detected after the batches had already been distributed to hospitals and clinics in several provinces. Only then did ANMAT issue an alert and order the immediate withdrawal from the market.
The investigation and the scope of the case
The first cases appeared in May 2025 and were interpreted as isolated nosocomial infections. However, microbiological analyses confirmed that the bacteria came directly from the drug.
● Deaths under investigation (Federal Justice): at least 76 fatalities could be linked to the use of the contaminated ampoules, according to the case overseen by Judge Ernesto Kreplak.
● Official health figures: the Ministry of Health, in its Epidemiological Bulletin, recognizes 48 deaths, a significant discrepancy that generates controversy.
Details of the implicated batches:
Batch 31202 – produced on December 18, 2024 (154,530 ampoules):
● 42,502 (27.5%) administered to patients.
● 64,003 recovered by justice.
● 47,593 in judicial storage.
● 432 unaccounted for.
Batch 31244 – same amount of ampoules (154,530):
● 121,233 recovered by justice.
● 30,197 in judicial storage.
● 3,100 missing units according to preliminary data.
Measures and consequences
ANMAT prohibited the marketing and use of the affected batches and ordered hospitals and clinics to identify and return the ampoules.
Justice charged executives of the involved laboratories, ordered the seizure of assets, and prohibited them from leaving the country.
This episode is considered one of the most serious health crises in Argentine history related to medications, and it reignited the debate on:
● The effectiveness of quality controls.
● The traceability of drugs.
● The need to strengthen health surveillance.
A turning point for pharmaceutical safety
The case of the contaminated fentanyl ampoules not only involves a human tragedy but could mark a before and after in pharmaceutical regulation in Argentina.
Relatives of victims demand justice, transparency, and exemplary sanctions, while the health system faces the challenge of regaining the trust of patients and professionals. The big question now is whether the country will learn from this crisis to prevent history from repeating itself.
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