Categories: News

The government suspended the activity of the laboratory involved in fentanyl deaths


The Deaths for the use of fentanyl contaminated In institutions of the public and private health system of Argentina added a chapter on Tuesday when confirmed that The Government ordered the SUSPENSION OF ACTIVITIES in the two floors that belong to the HLB Pharma Group laboratory, which produced the compound that generated a Ongoing outbreak of serious invasive infections associated with its use. In addition, one set up one Criminal complaint. The inhibition, which It is a step prior to the closureit was determined in the Provision 3158/2025 of the National Administration of Medicines, Food and Medical Technology (ANMAT), which depends on the Ministry of Health, and arrives after Nine deaths and a total of 20 cases will be recorded. In the four articles that the decision published in the Official Gazette has, on the one hand inhibited the productive activities of the firm HLB Pharma Group SA. In its Tomkinson 2054 Avenue plant, in San IsidroProvince of Buenos Aires; and also from LABORATORIOS RAMALLO SA (which produces for HLB Pharma and where contaminated fentanyl was elaborated), located on Agustín Rocca engineer in that city, also Buenos Aires. So it is Ramallo laboratories by dentro -reliable branching, prohibited the use, distribution and marketing throughout the territory of Argentina of all products registered in the name of HLB Pharma “Until the technical and health conditions are found to raise this measure.” I could know The nationfrom the personal Monday of the ANMAT, it was deployed in the two plants, he did inspections and, from the inhibition, in the firm they cannot work or make movements, not even documentation. In addition, with all the material collected, now the government could ask justice that CLAUSURE The two venues. Criminal complaint against HLB Pharmawhich fell to Federal Court No. 1 of the city of La Plata, by the doctor Ernesto Kreplak. The documentation that revolved among national officials regarding these companies that are in the midst of the controversy slides that entrepreneurs Ariel García Furfaro and Jorge Salinas would be responsible for HLB Pharma, Ramallo Laboratories and also Apollo Laboratoriesbased on requests for reports on these firms that were made in the Chamber of Deputies of the Nation. This is Ramallo Laboratories inside Ramalloes Laboratories that companies did not go unnoticed in the public field. He Apollo Laboratory would have been involved in a cause of Paraguay medication smuggling In the early 2000s. In addition, on June 24, 2016, a burst In the boiler of the plant that had located in Rosario, in the La Tablada neighborhood, where 120 operators who made physiological serum for the national state and the provincials worked. Two months before that, the civil and commercial judge Elvira Sauan had declared the bankruptcy of the company. After, already in 2017, the entrepreneurs bought HLB Pharma And the name of the laboratory jumped media because it was in the negotiations to distribute the vaccine Sputnik against him COVID-19 In Argentina, in the middle of the pandemic. An investigation carried out by The nation In January 2021, he details that when the arrival of the Russian vaccine was negotiated, from HLB Pharma Group They assured before the Justice that an agreement for the purchase and distribution of 50 million doses for Argentina and other countries in the region through a Joint Venture with the Corporate Center of the Direct Investment Fund of Russia (RDIF) were signed. Once the numbers were ordered, I could enter the Sputnik V business that included, in addition to the exclusive representation of the product in the country, its production in Argentina. At that time, HLB Pharma was one step away from closing its preventive call, but the contract between the local company and the RDIF was never signed, they recognized from the company before the consultation of The nation.In the middle of the transactions, representatives of the firm met with officials of the Alberto Fernández Government And they traveled to Russia with the then Minister of HealthCarla Vizzotti. However, from the firm they indicated that the pre -agreement they had with representatives of the Russian Fund was not signed and accused in that section the national management. “Our plan was not to be government intermediaries,” said sources from HLB Pharma to The nation In 2021. In September, they added, the government “changed her mind” and was interested in Sputnik V. “We felt mistreated and humiliated by Argentine officials. They treated us very badly. The government decided to run the business. During the first trip to Russia, they used our know-how To open the negotiations, they asked us for information and then decided that we could not sell the vaccine ”they marked. This year both HLB Pharma and Ramallo laboratories received a series of Attention calls. On February 24, the ANMAT ordered that Ramallo laboratories could not continue with its productive activity because during an inspection process they were detected significant deficiencies, classified as criticism and seriousin management of the pharmaceutical quality system, in production, in human resources, in deposits and in quality control, among others. “These breaches compromise the quality, safety and effectiveness of the products elaborated”, They pointed out at the beginning of the year from the agency. A few days later, on February 28, the ANMAT prohibited the use, marketing and distribution throughout the country of Two dopamine lots produced by HLBwhile on April 16 they ordered the firm that will withdraw all the lots of propofol hlbl from the marketOn April 24, the use, marketing and distribution of a series of diclofenac and morphine that produced HLB Pharma was prohibited, and the firm was ordered to withdraw the market of these products.For last, from the government justified that the ANMAT declared last Thursday, May 8, the “Health alert” (which is a step prior to the prohibition) to indicate that the HLB/Fentanyl Finanil (citrate) should not be used throughout the national territory. “It is presented with a concentration 0.05 mg/ml, in the pharmaceutical form injectable solution, Lot 31202expiring in September 2026. This medicine came in a presentation per 100 ampoules for 5 milliliters, certificate No. 53,100, being the lot in question Research object for quality diversion“, They pointed out from the specialized organizations of the Casa Rosada. That was after the blisters of that lot were used in Intensive therapy of the Italian hospital in La Plata And a Pneumonia outbreak which affected 18 patientsnine of which died. All started with fever due to blood bacteria and hypotension, and ended with a Septic shockthat in half of them caused death. In the Italian hospital in La Plata, the first outbreak Ignacio Amiconiiniinformation of the ongoing research was detected indicated that it would have been detected in the ampoules of fentanyl contamination with the bacteria Ralstonia Pickettii and Klebsiella pneumoniae Metalobethalactamase Producer (MBL). Both were present in the samples taken to the patients of La Plata and also in two other cases that are investigated in Rosary.


Omi

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