Official announcements
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Recall
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Medicines
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19/09/2016
In a letter dated 19.09.2016, the marketing authorization holder informed its customers that yellow-brownish particles had been detected in the above batch and that a recall was therefore being carried out. The particles are traces of corrosion…
Recall
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Medicines
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16/09/2016
The marketing authorization holder informed its supplied customers in a letter dated 13.09.2016 that its batch of "Chlorhexidine digluconate Sage 20 mg/ml impregnated wipe" must be recalled as it is possibly microbiologically contaminated withbecause…
Safety warnings
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Medicines
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06/09/2016
Novo Nordisk is recalling 55 lots of GlucaGen HypoKit worldwide because in some cases the needle has come loose from the pre-filled syringe. In Austria, one batch is affected.
Recall
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Medicines
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06/09/2016
The marketing authorization holder has informed its customers as well as pharmacies, institutional pharmacies, physicians in private practice and patient organizations by letter dated 06.09.2016 that there is a possibility of a detached needle from…
Recall
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Medicines
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17/08/2016
The marketing authorization holder has informed its supplied customers in a letter dated August 2, 2016, that the above-mentioned batches of "Amiodarone 150 mg i.v. Carino" are being recalled. During a routine check of reserve samples,…
Recall
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Medicines
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11/08/2016
The marketing authorization holder informed its supplied customers in a letter dated August 10, 2016, that the above-mentioned batches of Kogenate®Bayer are being recalled. Stability data for these batches indicated a faster than usual decline in…
Recall
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Medicines
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10/08/2016
CSL Behring as distributor of the product Helixate®NexGen has, in coordination with the marketing authorization holder Bayer Pharma AG, informed its supplied customers by letter dated August 8, 2016, that above mentioned batches of Helixate®NexGen…
Recall
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Medicines
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05/08/2016
The marketing authorization holder has informed its supplied customers in a letter dated August 4, 2016, that after the application of "Nutriflex Lipid special Emulsion for Infusion " of the batch 160338052 individual cases of fever and chills have…
Recall
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Medicines
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21/07/2016
The distribution company has informed its supplied customers in a letter dated 21.07.2016 that in the instructions for use of this batch the wrong daily maximum dose of ten capsules is indicated. The correct maximum is five capsules per day. This…
Recall
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Medicines
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15/07/2016
The marketing authorization holder has informed its supplied customers in a letter dated 14.07.2016 that the title of the leaflet is incorrect. The active strength is listed as 5 mg instead of 10 mg and therefore the affected batches of "Amlodipine…