The marketing authorization holder informed its supplied customers in a letter dated November 20, 2013, that the above-mentioned batches would be recalled from the market because values for the parameter particle size outside the approved specification were found in the course of routine stability tests.

The company responsible for distribution, sigma-tau ArzneimittelGmbH, 40212 Düsseldorf, Germany, informed its supplied customers on November 15, 2013, that individual containers of the above-mentioned batches may have fine cracks that may lead to leakage (presumed incidence: 1/5,000), which may pose a risk of microbial contamination. Replacements…

Due to a possible quality defect, the companies Sigma-Tau Arzneimittel GmbH and Sigma-Tau Rare Diseases S.A. have decided to recall the above mentioned batches of Oncaspar® Injection Solution.Both companies have been informed by the manufacturer of the bulk Oncaspar® Injection Solution, Sigma-Tau PharmaSource Inc, Indianapolis, of the possibility…

Due to a technical defect, there is a possibility in a small number of Jext epinephrine auto-injectors that the epinephrine is not correctly applied to the muscle when the auto-injector is triggered.

In a small number (0.04% corresponds to 4/10,000) of Jext® pre-filled pens, the adrenaline injection may not be carried out in case of need due to a technical defect. The affected batches will therefore be replaced immediately. To ensure immediate supply, pharmacies will exchange the Jext® prefabricated pens for EpiPen® prefabricated pens of the…

Due to a manufacturing problem during the filling of the cartridges, individual products of the above mentioned batches of "NovoMix® 30 FLexPen®" may have an insulin content that is too high or too low. According to information from the Danish marketing authorization holder, NovoNordisk A/S, the insulin concentration may deviate in a small number…

The marketing authorization holder has informed its supplied customers in a letter dated 11.10.2013 that complaints have arisen describing the disintegration of the pen after repeated use. Since the pen can no longer be used after this, a precautionary recall is being carried out.

Several regions are affected by WNV infections.

NAT testing was implemented in the Nestos and Kavala regions. A total of 11 cases documented.

On October 8, 2013, the marketing authorization holder informed its customers that injection vials may have an externally invisible defect under the crimp cap due to the capping machine and that product leakage may occur when the vial is shaken. Since sterility cannot be guaranteed, this batch is being recalled. This medicinal product is authorized…