In Argentina you don’t win for scares. This week, the prior censorship exercised by the Government and the complaints for alleged corruption overshadowed the drama of the contaminated fentanyl, one of the largest recent health disasters in the country, with 122 fatalities and hundreds of affected. But, outside, things happened and the case is not forgotten.
The investigations carried out in Argentina found that there were fentanyl ampoules contaminated with bacteria, and that caused invasive infections and deaths, both in public and private health institutions in various localities of the country. This week, the World Health Organization (WHO) He announced an alert for contaminated blisters.
“This WHO alert about medical products refers to six HLB fentanyl lots (fentanyl citrate) of substantial quality detected in Argentina. Fentanyl citrate injections are opioid analgesics that are used to relieve pain during and after surgical interventions. They are also used to reduce the respiratory rate of patients undergoing mechanical ventilation and to relieve the intense pain of people with chronic diseases, ”is established on the alert of the world health organization.
In May 2025, WHO confirmed the existence of reports related to a mortal outbreak of bacterial infections in Argentina linked to a lot of Fentanyl HLB Injectable (lot 31202) Contaminated with strains of Klebsiella pneumoniae and Ralstonia Picyttii resistant to antimicrobial. The information currently available indicates that several HLB fentanyl lots are contaminated and, therefore, must be withdrawn in Argentina.
Breaches Why does WHO say that medication is a substandard? Because it does not meet quality standards or established requirements. HLB fentanyl (fentanyl citrate) is administered through an injection to people in a critical state of health or subject to surgical interventions, and that puts them in a particularly vulnerable situation. “For this reason,” they affirm from WHO,, sterility and quality of products are fundamental for their safety. ” As “important” risks are involved for patients, “it is essential to detect and remove from the circulation these substandard quality products.”
The Argentine Prosecutor’s Office investigating the case identified various specific failures in the production of fentanyl in the HLB Laboratories Pharma and Ramallo Sa. These failures were considered serious and included breaches of manufacturing protocols, lack of quality controls, and inappropriate hygienic conditions.
From WHO it is also warned to other countries and takes into account the possible circulation of contaminated blisters in the black market.
“Health professionals must notify the National Regulation Agency or the National Pharmacovigilance Center the detection of substandard quality products and any incident related to adverse effects or the absence of the planned effects.
For WHO experts, it is necessary to “redouble surveillance and diligence in the supply chains of those countries and regions that may be affected by these substantial quality products. It is also advisable to increase the surveillance of the informal or not regulated market.”
Argentine Justice investigation estimates that near 300,000 Fentanyl ampoules They were exposed to contamination with resistant bacteria, although not all were applied. That is why the real number of affected people is still under tracking.
WHO is strict: “Health authorities are urged, national regulation agencies and security forces to which, if these products are detected in their country, they immediately notify the WHO.” And recommend that people who are in possession of any of these products that do not use them and notify the organization if you have information about the manufacture or supply of lots number 31200, 31202, 31244 to 47, inclusive.
Among other problems, the Argentine justice determined that the contaminated lots were released before the end of the mandatory simulation trials, which prevented the early detection of failures. There were also critical failures in the water for injectables because the necessary steps to guarantee their sterility and purity were not followed.
In addition, fentanyl citrate that was close to its expiration or expired date was used, which increased the risk of contamination.
