The marketing authorization holder has informed its supplied customers in a letter dated 21.08.2015 that the batches listed above were manufactured with an active ingredient batch that may be contaminated with particles of the manufacturing equipment. As there could be irritation of the nasal mucosa/skin due to these particles in the nasal…

The marketing authorization holder has informed its supplied customers in a letter dated 13.07.2015 that the above batch is being recalled as a precautionary measure because an outdated package insert was enclosed.

In a letter dated June 26, 2015, the marketing authorization holder informed its customers that ongoing stability tests have revealed values outside the specification for the degradation product ketolactam. The reason lies in a too long holding time of the bulk product and concerns two batches in Austria, which will probably not comply with the…

The parallel distributor has informed its supplied customers in a letter dated June 2, 2015, that the affected batch A229473D is being recalled due to a falsification of the packaging. The marketing authorization holder "Gilead Sciences International Limited" was notified by another parallel distributor of an anomaly on the packaging of batch…

The marketing authorization holder has informed its supplied customers that a slightly increased level of oxidized methionine was found in stability tests after 12 months of storage. Methionine is part of the structure of erythropoietin, and oxidation of methionine in the formulation is a known, expected reaction and thus part of the testing and…

Sandoz GmbH has informed all supplied customers in a letter dated 20.05.2015 that deviations in the release of the active ingredient were found in stability tests for batches with the old shelf life of 36 months. These deviations are due to the aging process of the tablet film layer, which is intended to prevent premature release of the active…

The distribution company informed its supplied customers by letter dated 01.04.2015 that various finished product batches from a single bulk are being recalled because black visible particles were detected.

In a letter dated March 26, 2015, "Bayer Austria Ges.m.b.H." informed its supplied customers that there was a single deviation in the ambient monitoring during aseptic filling and therefore the four batches listed above are being recalled as a precautionary measure.

The marketing authorization holder has informed its supplied customers both by telephone and in writing that individual leaking sachets have been detected, which affect the product quality due to moisture penetration. Thus, an exchange of the affected batch was initiated.

The distribution company has informed its supplied customers in a letter dated 25.02.2015 that in the instructions for use of this batch the wrong daily maximum dose of ten capsules is indicated. This medicinal product is placed on the market in Austria within the scope of a transfer notification pursuant to the Austrian Medicinal Products Import…