Information on voluntary recall of the one batch of the medicinal product Esomeprasol PharmaS 40 mg gastro-resistant tablets
PharmaS d.o.o., the marketing authorisation holder and manufacturer for the medicinal product Esimeprazol PharmaS 40 mg gastro-resistant tablets, has informed the Agency for Medicinal Products and Medical Devices (HALMED) about the voluntary recall from wholesalers of the batch 3880213 of this medicinal product.
The recall of the aforementioned batch is being carried out due to a labelling error of the dose on the lateral package side, where it is indicated 20 mg instead of 40. The reason for recall is a possible mistake at dispensing and therefore a possibility for the patient to take a wrong dose of the medicine.
The marketing authorisation holder has informed the wholesalers about it and requested from them to stop the distribution. Additional instructions for dispensing of this batch will be sent to pharmacies today.
We remind healthcare professionals that they should report any adverse reaction to HALMED, as well as quality defect. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED via form or on-line application, with recommendation regarding any adverse reaction they discover to consult with their doctor or pharmacist about the continuation of their therapy.