Information on voluntary recall of the one batch of the medicinal product Esomeprasol PharmaS 40 mg gastro-resistant tablets
02.01.2014
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.
Detailed information is available under the link below.
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