Overview
- Brazil’s drug regulator issued the orders Wednesday in Resolution RE 1,380, published in the Diário Oficial da União.
- Anvisa recalled Hypofarma’s dipyrone monohydrate 500 mg/mL injection, lot 24112378, after confirming foreign particulate in the solution.
- The affected dipyrone lot is sold in boxes with 100 glass ampoules of 2 mL each, and its sale, distribution, and use are now barred nationwide.
- All lots from Mali Produtos Para Saúde LTDA were suspended for testosterone esters, nandrolone, tirzepatide, and semaglutide, covering sales, distribution, compounding, advertising, and use.
- Regulators cited failures that include poor storage and transport, unqualified raw‑material suppliers, missing purity and identity tests, broken cold‑chain controls, and no proof of input quality, with Hypofarma stating to g1 that it follows strict standards.