The marketing authorization holder has informed its supplied customers in a letter dated 09.05.2016 that due to a technical error during production, there are residues of corrosive agents in the dry substance. Therefore, the two above mentioned batches of "Rifoldin 600mg dry substance for infusion preparation with solvent" are recalled as a…

The marketing authorization holder has informed its supplied customers by letter dated April 20, 2016, that an internal quality control has detected an undercutting of the phenol content and therefore the affected batches of the Prick Test Solution Pineapple will be recalled.

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.

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.

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.