Notice on recall of the batch 242562 of Nitronal solution for infusion 50 ml (1 mg/ml) (glyceryl trinitrate)
11.11.2015
The Agency for Medicinal Products and Medical Devices (HALMED) would like to inform of the recall of the batch 242562 of Nitronal solution for infusion 50 ml (1 mg/ml) (glyceryl trinitrate) of the manufacturer Pohl Boskamp, Germany, due to a suspected quality defect. The recall is conducted to the hospital level, or the delivery site to patients.
The manufacturer’s decision on recall of this batch is taken as a precaution after discovery of an impurity in one of the ampules.
There is no authorised medicinal product of the same pharmaceutical form with the same active substance, containing the active substance glyceryl trinitrate. This batch of Nitronal has been placed on the Croatian market upon request of certain hospitals based on which HALMED gave its accord for interventional import of the medicine. There is no other batch of this medicine in distribution in Croatia, and the normalisation of the supply chain and enter of another batch not affected by this quality defect is expected by the end of the month.
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, with recommendation regarding any adverse reaction they discover to consult their doctor or pharmacist about the continuation of their therapy.
