The drug, food and medical technology authority (Anmat) has banned the drug “Ibuflamar-p Ibuprofen with Paracetamol”, manufactured by Indoco Remedies Ltd., Bolivia, and withdrew it from the market because the drug is not registered in the country and is therefore represented a potential risk to humans.
With regulation 6738/2021, published in the Official Gazette this Thursday, the agency extended the ban to all batches and presentations of the product until both the manufacturer and its distributor, the company San Fernando Sociedad de Responsabilidad Limitada, completed the registration process completed .
According to Anmat, the product is “a drug that has not been registered with this health authority, the origin and manufacturing conditions of which are unknown and therefore poses a risk to the health of potential patients to whom it could be administered”.
The authority was on the dissemination of this product on July 1st as a result of the kidnappings by the Department of Crimes against Public Health and Counterfeit Medicines of the Federal Police in the context of the procedure No. 891/2019 with the title. attentive: “María Fernanda Vargas Gutiérrez and others to investigate criminal offenses”, with the intervention of the National Prosecutor for Criminal and Federal Correctional Affairs No. 1.
Then, Anmat confirmed that not only the laboratory and the dealer had no approval, nor was the Ibuflamar product registered in the Register of Medicinal Specialties (REM). Therefore, its ban was ordered and it was requested that all provincial health authorities be notified.
In addition, the Anmat has withdrawn another drug known as “Hutrope FlexPen”, a “recombinant growth hormone” that can be administered from “a solution for injection in a prefilled device for subcutaneous use”. The company took the action, alerted by Eli Lilly Inter-America Inc, which denounced that it was a counterfeit of their own product called “Hutrope”.
It also banned the distribution of various “Mosaic Ultra” heart valve units after the import company Demedic Sociedad Anónima stole four of them. They were reportedly stationed at the Sanatorio de la Trinidad San Isidro to cover emergency operations.
Taken from page 12.