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 concentrations of estradiol in accordance with Article 31 of Directive 2001/83/EC, the following…

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.

The distributor informed its supplied customers that during the daily sterility test control of the final products of batch 02-150112 a turbidity was detected and therefore a potential contamination had to be assumed.

The marketing authorization holder informed its supplied customers in a letter dated January 13, 2015, that the package leaflet in Greek was enclosed with individual packages of batch 42053 and that a precautionary recall is therefore being carried out.

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.

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…

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.

The marketing authorization holder informed its supplied customers in a letter dated October 21, 2014, that the affected finished product lot 4E915 was produced with an aciclovir active ingredient lot that does not meet the specifications regarding particle size. Because the amount and size of potential metallic particles in the finished product…

The distribution company informed its customers in a letter dated October 13, 2014, that after 3 years of storage at 30°C and 75% humidity and after 6 months of storage at 40°C and 75% humidity, increased levels of known and unknown impurities as well as a change in the color of the solution were detected in stability tests, so that the affected…