The Entidade Reguladora Independente da Saúde (ERIS) has suspended marketing and ordered immediate withdrawal of two batches of Azitromicina Alvyx 40 mg/15 ml powder for oral suspension.
The batches are V0011500V and V0021501V, with expiry 11/2026. The product is manufactured by Laboratórios Basi – Indústria Farmacêutica, S.A.
The action follows a spontaneous notification reporting small dark dispersed particles in the powder and markedly dark colouration after reconstitution with water, both non-conforming to manufacturer specifications. ERIS states this indicates altered physical properties that may compromise quality.
Entities holding the affected batches must not commercialise, dispense or administer them. They must withdraw the product from distribution and use circuits and return it. Patients using either batch should request replacement with a pack from an unaffected batch as soon as possible.
Sources
- Primary: Entidade Reguladora Independente da Saúde (ERIS) — https://eris.cv/index.php/noticias/1064-eris-determina-a-suspensao-da-comercializacao-e-a-recolha-de-lotes-do-medicamento-azitromicina-alvyx
