The national medicines authority, Infarmed, ordered the immediate suspension of the commercialization of batch L25428A of the medication Salofalk, which contains Mesalazine 3000mg in extended-release gastroresistant granules. The decision was made after a deviation related to the batch serialization was identified, that is, a problem in the individual identification system of the packaging. The batch in question has validity until November 2029 and consists of packages of 60 sachets.
The measure covers the entire commercialization circuit of the medication, including pharmacies and other entities that have units of this batch in stock. These must proceed with the return of the medications and remove them from sale, dispensing, or administration. The responsibility for the recall lies with Dr. Falk Pharma Portugal, the company responsible for the production of Salofalk, specialized in digestive and metabolic medicine.
Despite the suspension of sales, Infarmed leaves a clear warning to patients who are currently using the medication: the treatment should not be stopped on their own initiative. The authority recommends that patients contact their attending physician as soon as possible so that the need to maintain the medication or proceed with its replacement with a suitable alternative can be evaluated.