Distribution, Manufacturing and Inspection

Recall of the batch AIIM/1P of Torisel with corresponding solvent batch AHZW/99

07.10.2014

Pfizer Croatia d.o.o., the Croatian representative of the marketing authorisation holder for Torisel has notified the Agency for Medicinal Products and Medical Devices (HALMED) on the recall of the batch AIIM/1P of this medicine with corresponding solvent batch AHZW/pp from the market due to a quality defect.

The representative of the marketing authorisation holder will notify all wholesalers about the recall and will ask them to discontinue delivery of this batch and withdraw all distributed quantities of this medicine from pharmacies and hospitals.

We remind healthcare professionals that they should report any adverse reaction, as well as quality defect to HALMED. 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 their doctor or pharmacist about the continuation of their therapy.

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