Infarmed recalls batch of Salofalk intestinal medication

Infarmed has announced the immediate market withdrawal of a specific batch of the medication Salofalk, which is used to treat inflammatory bowel diseases such as ulcerative colitis. The recall affects batch L25428A (expiry 11/2029) of the Salofalk Mesalazine 3000 mg gastro-resistant prolonged-release granules, sold in packs of 60 sachets.

The decision follows the detection of a deviation related to the serialization of this specific batch. Dr. Falk Pharma Portugal, the manufacturer, will proceed with the collection of the identified lot. Authorities have instructed all entities holding this batch in stock to cease sales, dispensing, or administration and to proceed with its return.

Despite the recall, Infarmed advises patients currently undergoing treatment with this batch not to interrupt their medication without consulting a physician. Patients are encouraged to contact their doctor as soon as possible to discuss the potential need for an alternative medication.