Isotretinoin is a highly effective vitamin A analogue that has been used since the early 1980s to treat severe, therapy-resistant forms of acne. When isotretinoin is taken during pregnancy, the risk of severe congenital malformations or spontaneous abortion is comparable to that after exposure to thalidomide. Isotretinoin is therefore absolutely…

The distributor has informed its supplied customers in a letter dated 18.12.2014 that there is a possibility of incorrect labeling or batch submixing with 100 mg/ml nerfasin vials in the above batch. To date, there have only been reports of this from the French market, but a precautionary recall is being carried out in order to rule out any risk to…

The marketing authorization holder has informed its supplied customers by letter dated 16.12.2014 that a quality defect with regard to the formulation or the homogeneity of the product has been detected and therefore a recall of all batches will be carried out. This veterinary medicinal product is placed on the market in Austria within the scope of…

The distribution company has informed its supplied customers in a letter dated December 16, 2014, that in individual cases a dosage inaccuracy (slight underdosage) has been detected in dosing pumps in the prepackages of Axura 5 mg/pump stroke, 50 ml solution for oral use. Therefore, the affected batches are recalled by wholesalers, pharmacies as…

The distribution company has informed its supplied customers in a letter dated December 16, 2014, that in individual cases a dosage inaccuracy (slight underdosing) has been detected in dosing pumps in the prepackages of Ebixa5 mg/pump hub, 50 ml solution for oral use. Therefore, the affected batches are recalled.

An inspection by the French Medicines Agency (ANSM) of the research service provider GVK Biosciences in Hyderabad (India) has revealed serious deficiencies in the conduct of bioequivalence studies for the approval of generic drugs. There is suspicion that relevant study parameters were deliberately falsified, which is a massive violation of Good…

An inspection by the French Medicines Agency (ANSM) of the research service provider GVK Biosciences in Hyderabad (India) has revealed serious deficiencies in the conduct of bioequivalence studies for the approval of generic drugs. There is suspicion that relevant study parameters were deliberately falsified, which is a massive violation of Good…

The marketing authorization holder informed its customers supplied with the product in a letter dated December 2, 2014, that all batches marketed had been reviewed because deviations had been identified in stability tests. For Austria, these tests identified a total of seven batches that could show an increase in the degradation products ketolactam…

Austria has been informed by the Italian Medicines Agency (AIFA) of a precautionary suspension of two batches (142701 and 143301) of the influenza vaccine Fluad. The reason for the suspension is the occurrence of serious adverse events that have been reported in a temporal relationship with the vaccination. Currently, there is no confirmed causal…

The distributor has informed its supplied customers in a letter dated 19.11.2014 that there is a possibility of crystallization (particle formation) in the injection solution of the above batch. The crystals observed are probably precipitated progesterone. The recall leads to a temporary restriction of distribution.