The National Authority for Medicines and Health Products (Infarmed) ordered the immediate suspension of commercialization and voluntary recall of a batch of the medication Salofalk throughout the national territory. The regulatory decision was made following the detection of a deviation in the technical process of serialization of the drug's packaging, which contained 3,000 milligrams in prolonged-release granules. The batch in question has reference L25428A and its expiry date expires in November 2029. The marketing authorization holder is Dr. Falk Pharma Portugal, which formally communicated the existence of a non-conformity in the packaging circuit.
Serialization constitutes an indispensable regulatory requirement in the European space, intended to ensure the complete traceability of each unit through unique two-dimensional codes. The compliance failure in the coding of the boxes compromises the automatic mechanisms of verification and authentication at the time of dispensing, prompting the preventive recall. Infarmed activated standard blocking protocols at wholesalers, community pharmacies, and hospital units, determining that all packages of the batch must be isolated and segregated from inventories.
Infarmed issued recommendations to patients who have already purchased the product, warning that they should not discontinue medication abruptly without prior clinical guidance. Patients should contact their prescribing physician or go to their usual pharmacy to proceed with replacement by another valid batch or by an equivalent alternative. Any doubts about adverse reactions or formulation efficacy should be reported to health professionals. Discontinuation without medical supervision in chronic inflammatory pathologies carries substantial risks of symptom exacerbation.
Salofalk contains the active substance mesalazine, a first-line intestinal anti-inflammatory used in the treatment of ulcerative colitis and Crohn's disease. The prolonged-release granule presentation allows the administration of high doses in a single daily dose. Pharmacies must store the recalled packages in a quarantine area and return them to wholesale distributors for subsequent incineration or reprocessing. Infarmed guarantees that the availability of other batches and presentations of the same active substance is safeguarded to meet the population's needs.
