The marketing authorization holder informed its supplied customers by letter dated February 03, 2014 that infusion bags of 0.9% NaCl 500ml Viaflo with Austrian presentation (Ch.No. 13H31E1A) were found in a carton of 0.9% NaCl 500ml Viaflo with…

The marketing authorization holder informed its supplied customers in a letter dated 31.01.2014 that a quality deviation with regard to product- and process-related impurities was found in stability tests for certain batches.

The marketing authorization holder informed its supplied customers in a letter dated 23.01.2014 that the batches listed show deviations in dissolution. The release of the active ingredient amitriptyline after four hours is slightly higher than…

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…

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…

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…

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…

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…

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…

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.