The marketing authorization holder informed its supplied customers in a letter dated 19.04.2016 that an error in the filling process was detected at the manufacturer. The error results in a few vials possibly containing a too high concentration. The too high concentration results from the partial evaporation of the solvent ethanol, but the total…

The marketing authorization holder has informed its supplied customers in a letter dated 20.04.2016 that the marketing authorizations of medicinal products containing fusafungin (Locabiosol / Bioparox / Locabiotal / Fusaloyos as oral spray, nasal spray or as solution) will be revoked within the EU.These medicines are used for the treatment of upper…

The marketing authorization holder has informed its supplied customers in a letter dated April 15, 2016, that a possible non-sterility cannot be excluded and therefore a precautionary recall is being carried out. This recall results from an inspection by the Spanish surveillance authority (AEMPS) at the manufacturer Inmunotek S. L., during which it…

In a letter dated April 13, 2016, the marketing authorization holder informed its customers that the above-mentioned batch of "Curatoderm - Ointment" was found to be mixed with "Amciderm - Cream" and is therefore being recalled. "Amciderm - Creme" is not approved in Austria.

Due to legal requirements (Reg. (EC) 726/2004, Article 25a), EMA is obliged to set up a database for periodic safety update reports (PSUR) and the associated opinions. All PSUR procedures must be submitted electronically (according to Reg. 726/2004, Article 107b paragraph 1 and Article 28(2)). Since September 1, 2015, the use of the xml file for…

The pharmaceutical company "Amomed Pharma GmbH" has informed its supplied customers by letter dated 11.03.2016 that in the course of stability testing a clear brown coloration of the solution was detected in some ampoules. This brown coloration results from a production deviation and occurs after longer storage at room temperature.

Recently, pyrrolizidine alkaloids have also been detected in herbal preparations made from plants that do not biosynthesize pyrrolizidine alkaloids. Studies suggest that contamination with weeds may be responsible. Since even very few individuals of weeds (such as species of the genus Senecio , greiseweed) can lead to toxicologically relevant…

Agepha Pharma has informed its customers in a letter dated 24.02.2016 about the recall of the mentioned batch for the following reason: The composition of the eye drops has been changed (addition of povidone), but the official assessment of this change has not been made. The labeling, technical and directions for use do not correspond to the actual…

The company B. Braun Austria Ges.m.b.H. informed its supplied customers in a letter dated 28.01.2016 that due to customer complaints about leaking Ecoflac® plus infusion containers of the mentioned batch a precautionary recall due to possible leakage will be carried out.

The marketing authorization holder informed its supplied customers in a letter dated December 16, 2015, that a reduced active ingredient content was detected in the above batch in the course of routine stability tests, so that the shelf life until the stated expiry date is not guaranteed. The batch will therefore be exchanged for a replacement.