Brazil's Anvisa recalls antibiotics and saline solution over quality defects

The National Health Surveillance Agency (Anvisa) ordered the recall of two injectable antibiotics and a saline solution after identifying serious quality deviations. One lot of the antibiotic Polycid (manufactured by União Química) was found to contain a glass fragment inside a sealed ampoule. Another lot of clindamycin phosphate (produced by Hypofarma) showed an abnormal yellow colour and foreign particles in the solution. The saline solution Equiplex 9 mg/ml (manufactured by Equiplex Indústria Farmacêutica) was also deemed non‑conforming and removed from the market. The recalls were announced in the Official Gazette on 18 June; both manufacturers initiated voluntary withdrawals following Anvisa’s inspection. The agency also ordered the removal of all compounded preparations from the pharmacy S J do Jabour Ltda. Anvisa warned health facilities, distributors and consumers to verify the affected lot numbers and cease any use of the products.

The agency’s actions aim to protect public health by preventing distribution of products that may cause contamination, injury, or ineffective treatment.