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…

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…

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…

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…

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…

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…

The marketing authorization holder informed its supplied customers in a letter dated February 9, 2015, that the specified batches were being recalled because deviations from the specified dissolution value had been detected in the samples returned.

The marketing authorization holder has informed its supplied customers that due to Commission Implementing Decision C(2014) 6030 of 19.08.2014 concerning marketing authorizations for medicinal products for human use for topical application with high…

The distributor informed its supplied customers that during the daily sterility test control of the final products of batch 02-150115 a turbidity was detected and therefore a potential contamination had to be assumed.