The marketing authorization holder has informed its supplied customers in a letter dated 11.06.2018 that visible particles were found in part of a production batch during quality control. For this reason, the above batch is being recalled as a…

The marketing authorization holder has informed its supplied customers in a letter dated May 25, 2018, that a blister strip of another product from the same active ingredient group has been discovered in batch W28311 in a single package. As a…

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…

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…

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…

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…

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…

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…

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.