Official announcements
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Recall
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Medicines
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17/12/2015
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…
Recall
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Medicines
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10/12/2015
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…
Recall
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Medicines
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17/11/2015
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…
Recall
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Medicines
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30/10/2015
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.
Recall
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Medicines
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23/10/2015
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…
Recall
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Medicines
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23/10/2015
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…
Recall
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Medicines
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01/10/2015
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…
Recall
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Medicines
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27/08/2015
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…
Recall
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Medicines
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24/08/2015
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…
Recall
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Medicines
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14/07/2015
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.