Nine people have died in La Plata’s Hospital Italiano over the past month of an infection that is suspected to have been caused by a contaminated batch of medical-use fentanyl. Argentine food and drug monitoring agency ANMAT has ordered HLB Pharma, the pharmaceutical company that produces the drug, to halt operations until an investigation into the matter is completed.

ANMAT has also filed a criminal complaint against the laboratory, the first time in 15 years the agency has taken this step.

The case began after at least 20 people were infected by two bacteria that caused them pneumonia, Klebsiella pneumoniae MBL and Ralstonia Pickettii. Eighteen of them were infected in the Hospital Italiano in La Plata, Buenos Aires province. The other two were infected at a hospital in Rosario, Santa Fe.

The connection to the drug came following an investigation that found the same bacteria in a batch of fentanyl administered to the patients. Fentanyl is a strong opioid typically used to treat pain in patients that are in critical conditions or undergoing surgery.

“All of [the patients] had comorbidities and were in intensive care. The bacteria are very resistant to antibiotics,” an ANMAT source told the Herald. The agency is currently conducting tests to conclusively verify that the bacteria strain found in the patients is the same as the one present in the batch.

The investigation

According to a release by ANMAT, the situation was discovered after the Hospital Italiano reported the situation to them. After analyzing the 18 cases from that hospital, they found that “the affected patients had been administered the HLB fentanyl.” ANMAT was already monitoring the firm due to issues with production, traceability, and control of their products.

On May 8, ANMAT ordered all health centers in Argentina to stop using HLB Pharma’s fentanyl batch due to quality issues and halted all distribution and sales. On May 13, ANMAT also ordered it to stop using all of HLB Pharma’s products and ordered it to suspend operations. Pharmacies and hospitals that have them in stock must keep them in case of future searches that may aid in the judicial investigation.

On Thursday, the judiciary searched two of the firm’s laboratories in Buenos Aires province and a drug distribution center in Rosario. Authorities suspect that Laboratorio Ramallo, one of the labs in Buenos Aires, produced the contaminated batch, which the Rosario facility later distributed to the affected hospitals.

The Santa Fe and Buenos Aires provinces’ health ministries also halted the use of the drug in their public hospitals after learning about the cases. A source from the Buenos Aires provincial government told the Herald they have confirmed that the fentanyl batch was not in stock in any public hospital in the district but was unable to verify if the situation was the same with private clinics.