The marketing authorization holder has informed its supplied customers in a letter dated April 23, 2018, that a reduced ethanol content was detected during routine release testing. Therefore, the batch 7F307A on the market is recalled as a precautionary measure.

The marketing authorization holder has informed its supplied customers in a letter dated April 16, 2018, that a shortfall in the protein nitrogen content was detected during an internal quality control and that the affected batch of the Prick Test Solution Raygrass is therefore being recalled.

The marketing authorization holder has informed its supplied customers in a letter dated 23.03.2018 that increased anaphylactic reactions have been reported after administration of an identical product in France. For this reason, the above mentioned batches are recalled as a precautionary measure.

The marketing authorization holder has informed its supplied customers in a letter dated March 13, 2018, that cases of immune-mediated encephalitis and meningoencephalitis have been reported in patients treated with Zinbryta. This has resulted in an immediate suspension of the marketing authorization in the European Union, which means that all…

The marketing authorization holder has informed its supplied customers in a letter dated 22.02.2018 that it may not be possible to supply all doses. Therefore, the affected batch is recalled from the market as a precautionary measure.

The marketing authorization holder has informed its supplied customers in a letter dated February 13, 2018, that a minor contamination with Iopamidol has been detected in batch PQ0968 of the medicinal product "Zoledronic Acid STADA 4 mg/100 ml Infusion Solution". This can lead to adverse effects in correspondingly sensitized persons. Therefore, the…

The marketing authorization holder has informed its supplied customers in a letter dated 06.02.2018 that the translucent white cap on the tip of the BUCCOLAM application syringe can get stuck. This creates the possibility that administration may be delayed or the cap may accidentally enter the patient's mouth. For this reason, the affected batches…

The marketing authorization holder has informed its supplied customers in a letter dated 06.02.2018 that complaints about loose or rotating metal caps have been received. Therefore, the affected batches are recalled from the market as a precaution.

The marketing authorization holder informed its supplied customers in a letter dated January 23, 2018, that "Saroten 10mg Film-Coated Tablets" was placed on the market with an incorrect dosage information for the treatment of depressive disorders (episodes of major depression) in the package leaflet. Therefore, the two batches placed on the market…

The marketing authorization holder informed its supplied customers in a letter dated 27.11.2017 that the stability test did not comply with the test for gastric juice resistance. The potential impact on patient safety is assessed as low. All other batches available in Austria are not affected by this recall.