The marketing authorization holder informed its supplied customers in a letter dated December 23, 2013, that it cannot be ruled out that a frequent occurrence of hypersensitivity reactions may occur with this batch and that a precautionary withdrawal from the market is therefore being carried out.

The preparation Eldisin 5 mg dry ampoules (active ingredient: vindesine sulfate) has been approved in Austria since March 29, 1984. Vindesine is a cytostatic drug from the group of vinca alkaloids and has proven effective primarily in combination with other oncolytically active preparations as a last-line medication in the treatment of acute…

In a letter dated December 19, 2013, the marketing authorization holder informed its customers that an elevated level of a known degradation product of the active ingredient azithromycin has been detected in some vials and that a voluntary recall is therefore being carried out. This recall leads to an unavailability of "Zithromax i.v.".

Two autochthonous cases confirmed by PCR in Saint Martin.

WABOSAN Arzneimittelvertriebs GmbH has informed its supplied customers by letter dated 12.12.2013 that yellow-orange precipitations have been observed in batch Y260 in individual cases and therefore a precautionary recall is being carried out. This medicinal product is approved in Germany and is placed on the market in Austria within the scope of a…

In a letter dated December 9, 2013, the distributor informed its customers that in some cases the wrong pump sizes were included in batch EDEG-2.Packages of the 6 ml glass vials could contain pumps for the 33 ml vials, which could result in a 3.1 to 6.3-fold overdose during one application. In further investigations, particles were detected in 2…

All preventive measures for WNV transmission halted. Those entering the country from the Americas and Canada will continue to be barred from donating for 28 days.

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…