The distributor informed its supplied customers in a letter dated November 14, 2012, that a deviation in the manufacturing process, which was identified during an internal audit, may result in a reduced efficacy of the product. The potential reduction in efficacy does not pose a risk to patients, nevertheless a precautionary withdrawal of the…

The batches of Fluad and Sandovac influenza vaccines that were temporarily suspended two weeks ago due to a suspected quality defect (white particles in the bulk vaccine) were re-released on Nov. 9, 2012.

The marketing authorization holder informed its supplied customers in a letter dated October 24, 2012, that there is a possible pyrogen contamination in the two batches listed above.

Unless marketing authorization holders have made use of the legal provision (Section 94 c (10) of the Austrian Medicines Act) and submitted the required renewal documents for a specific medicinal product to AGES Medizinmarktaufsicht by June 30, 2012, this product can only be marketed until December 31, 2012. As of January 2013, these products are…

The marketing authorization holder, in consultation with the French authority, informed its supplied customers by letter dated 10/10/2012 that batch C079 is being recalled because it has a different volume/activity indication on the bottle label compared to the label on the lead container.

The BMG, BMI, BMF and BASG participated in this year's action week. The operation took place this year from 25.09. to 02.10.2012. In total, more than 100 countries worldwide participated in the organized action. The aim was to simultaneously and in a coordinated manner access illegal websites through which counterfeit medicines are distributed and…

Sanofi Pasteur MSD GmbH has informed its supplied customers in a letter dated 24.09.2012 that a voluntary recall is being carried out for the above-mentioned batches due to a possibly too low antigen content.

The active ingredient desmopressin (contained in various preparations) is approved for the treatment of primary enuresis nocturna, for the treatment of vasopressin-sensitive central diabetes insipidus, and for the treatment of nocturia associated with nocturnal polyuria in adults. The German Federal Office for Safety in Health Care recalls that the…

Ukrain is a medicinal product made from celandine extracts produced by the pharmaceutical company Nowicky Pharma. The drug was advertised in the EU as an alternative cancer treatment without a valid marketing authorization. In Austria, Nowicky Pharma was prohibited from importing, manufacturing and marketing Ukrain by official notice. On September…

The parallel distributor, HAEMATO PHARM AG; has informed its supplied customers by letter dated 5.9.2012 that the batches placed on the market by him are recalled, because tablets were found which are light blue and have "GILEAD" as tablet embossing. However, the tablets approved for use in the EU are blue and embossed with "GILEAD" on one side and…