The marketing authorization holder informed its supplied customers in a letter dated March 23, 2017, that there is a very low probability that the auto-injector of batch 5FA665N does not work correctly. Worldwide, there were two customer complaints outside of Austria where the pen could not be triggered during an intended use. Therefore, a…

The marketing authorization holder has informed its supplied customers in a letter dated 22.2.2017 that a possible contamination with another active ingredient has been discovered at the manufacturer. For this reason, a recall of the above-mentioned medicinal specialties is being carried out as a precautionary measure. Based on the available data,…

The marketing authorization holder informed its supplied customers in a letter dated December 15, 2016, that the vials may have cracks in the glass. Therefore, the affected batch is being recalled as a precautionary measure. The company is not aware of any product complaints or adverse reaction reports in connection with this defect.

In a letter dated December 13, 2016, the marketing authorization holder informed its customers that the above-mentioned batches of "Sertraline Sandoz" and "Lamotrigine Sandoz" are being recalled. During the routine incoming goods inspection on the part of the manufacturer, it was determined that a mix-up of an excipient had occurred. Instead of…

The marketing authorization holder informed its supplied customers in a letter dated October 12, 2016, that an impurity, "lmpurity D", was detected in the course of stability tests, which in the measured concentration does not indicate any health risk for patients. A recall of the above mentioned batches will be carried out on wholesale level.

The marketing authorization holder informed its supplied customers in a letter dated October 13, 2016, that an impurity, "lmpurity D", was detected during stability tests. In the measured concentration there is no health risk for the patients. A recall of all batches will be carried out at wholesale level.

Gedeon Richter Plc has informed their supplied customers by letter dated 12/10/2016 that above mentioned batches of "Lisvy 60 microgram/24 hours + 13 microgram/24 hours Transdermal Patch" are recalled. Stability data for these batches indicated a more rapid decline of the active ingredient gestodene. Since there is no assurance that the active…

CSL Behring as distributor of the product Helixate NexGen has, in coordination with the marketing authorization holder Bayer Pharma AG, informed its supplied customers in a letter dated October 11, 2016, that the above mentioned batches of Helixate NexGen are being recalled. Stability data for these batches indicated a faster than usual decline in…

In a letter dated 19.09.2016, the marketing authorization holder informed its customers that yellow-brownish particles had been detected in the above batch and that a recall was therefore being carried out. The particles are traces of corrosion caused by an unsuitable connecting piece during filling.

The marketing authorization holder informed its supplied customers in a letter dated 13.09.2016 that its batch of "Chlorhexidine digluconate Sage 20 mg/ml impregnated wipe" must be recalled as it is possibly microbiologically contaminated withbecause it may be microbiologically contaminated with "Burkholderia cepacia". Infected wipes show a light…