Official announcements
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Medicines
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05/07/2018
In a letter dated July 5, 2018, the marketing authorization holder informed its customers that the active ingredient manufacturer had detected the production-related impurity N-nitrosodimethylamine (NDMA) in the active ingredient valsartan.…
Recall
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Medicines
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05/07/2018
The marketing authorization holder has informed its customers in a letter dated December 31, 2009, that a production-related impurity has arisen at the active ingredient manufacturer during a synthesis step. This impurity is N-nitrosodimethylamine…
Recall
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Medicines
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05/07/2018
The marketing authorization holder informed its supplied customers in a letter dated December 31, 2009, that a production-related impurity occurred during a synthesis step at the active ingredient manufacturer's. The impurity is…
Recall
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Medicines
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12/06/2018
The marketing authorization holder has informed its supplied customers in a letter dated 11.06.2018 that visible particles were found in part of a production batch during quality control. For this reason, the above batch is being recalled as a…
Recall
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Medicines
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25/05/2018
The marketing authorization holder has informed its supplied customers in a letter dated May 25, 2018, that a blister strip of another product from the same active ingredient group has been discovered in batch W28311 in a single package. As a…
Recall
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Medicines
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23/04/2018
The marketing authorization holder has informed its supplied customers in a letter dated April 23, 2018, that a reduced ethanol content was detected during routine release testing. Therefore, the batch 7F307A on the market is recalled as a…
Recall
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Medicines
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17/04/2018
The marketing authorization holder has informed its supplied customers in a letter dated April 16, 2018, that a shortfall in the protein nitrogen content was detected during an internal quality control and that the affected batch of the Prick Test…
Recall
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Medicines
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23/03/2018
The marketing authorization holder has informed its supplied customers in a letter dated 23.03.2018 that increased anaphylactic reactions have been reported after administration of an identical product in France. For this reason, the above mentioned…
Recall
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Medicines
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15/03/2018
The marketing authorization holder has informed its supplied customers in a letter dated March 13, 2018, that cases of immune-mediated encephalitis and meningoencephalitis have been reported in patients treated with Zinbryta. This has resulted in an…
Recall
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Medicines
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22/02/2018
The marketing authorization holder has informed its supplied customers in a letter dated 22.02.2018 that it may not be possible to supply all doses. Therefore, the affected batch is recalled from the market as a precautionary measure.