Brasília – The National Health Surveillance Agency (Anvisa) has ordered the immediate suspension of all sterile compounded medications and hormonal implants produced by Elmeco Serviços Farmacêuticos e Treinamento Profissional Ltda. The measure covers manufacturing, commercialisation, promotion and use of the affected products.

The suspension follows a regulatory inspection which found widespread failures in good-manufacturing practices, including adulteration and high risk of microbial contamination in sterile preparations. The firm’s hormone-based products, specifically the drug “Nesterone” and testosterone implants, were also banned—Nesterone did not have proven safety and efficacy, and the implants lacked validation of sterilisation and risk control procedures.

Source: Anvisa

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