The marketing authorization holder and its distribution partner informed the supplied customers in a letter dated 14.12.2015 that after the introduction of a new IT system in the production facility "Stallergenes S.A." in Antony, France, difficulties were identified which resulted in operational malfunctions as well as in some incorrect deliveries.…

The marketing authorization holder informed its supplied customers in a letter dated December 4, 2015, that a precautionary recall of the batch R09199 will be carried out due to two complaints, in which an instruction leaflet of another product in English and French language was found in the package. Other batches, in particular batch R09199P, are…

The marketing authorization holder has informed its supplied customers in a letter dated 17.11.2015 that the above mentioned batch has a blue instead of green "flip-off" cap. To avoid confusion with "Propofol ratiopharm 10 mg/ml Emulsion for Injection/Infusion" (blue cap), batch A050007 is recalled as a precaution.

The marketing authorization holder informed its supplied customers in a letter dated October 29, 2015, that individual bags of the batches listed above may be affected by minor deviations in the content of the active ingredient ornithine aspartate.

The marketing authorization holder has informed its supplied customers in a letter dated October 22, 2015, that the stability of "Bravelle 75 I.U. Powder and Solvent for Solution for Injection" cannot be safely guaranteed until the stated expiry date based on the results of routine stability tests. Therefore, a precautionary recall of the batches…

The marketing authorization holder informed its supplied customers in a letter dated October 23, 2015, that a microbiological contamination was detected in the course of the inspection of reserve samples and that a recall of the above batch will therefore be carried out.

The marketing authorization holder informed its supplied customers in a letter dated September 17, 2015, that a slight shortfall in the protein content (PNU) was detected during internal quality control and that the affected batches of the Fusarium moniliforme and Quercus robur prick test solutions are therefore being recalled.

The marketing authorization holder informed its supplied customers in a letter dated August 25, 2015, that a different number of small particles was observed in some bottles of the above-mentioned batches after preparation of the ready-to-use solution. Thus, the result is out of specification with regard to the test "Description after preparation…

The marketing authorization holder has informed its supplied customers in a letter dated 21.08.2015 that the batches listed above were manufactured with an active ingredient batch that may be contaminated with particles of the manufacturing equipment. As there could be irritation of the nasal mucosa/skin due to these particles in the nasal…

The marketing authorization holder has informed its supplied customers in a letter dated 13.07.2015 that the above batch is being recalled as a precautionary measure because an outdated package insert was enclosed.