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…

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…

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…

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…

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…

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…

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customers in a letter dated 13.07.2015 that the above batch is being recalled as a precautionary measure because an outdated package insert was enclosed.

In a letter dated June 26, 2015, the marketing authorization holder informed its customers that ongoing stability tests have revealed values outside the specification for the degradation product ketolactam. The reason lies in a too long holding time…

The parallel distributor has informed its supplied customers in a letter dated June 2, 2015, that the affected batch A229473D is being recalled due to a falsification of the packaging. The marketing authorization holder "Gilead Sciences International…