Official announcements
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Replacement
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Medicines
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23/01/2014
The marketing authorization holder informed its supplied customers in a letter dated 23.01.2014 that the batches listed show deviations in dissolution. The release of the active ingredient amitriptyline after four hours is slightly higher than…
Replacement
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Medicines
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30/12/2013
The marketing authorization holder informed its supplied customers in a letter dated December 23, 2013, that it cannot be ruled out that a frequent occurrence of hypersensitivity reactions may occur with this batch and that a precautionary withdrawal…
Recall
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Medicines
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19/12/2013
In a letter dated December 19, 2013, the marketing authorization holder informed its customers that an elevated level of a known degradation product of the active ingredient azithromycin has been detected in some vials and that a voluntary recall is…
Replacement
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Medicines
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17/12/2013
WABOSAN Arzneimittelvertriebs GmbH has informed its supplied customers by letter dated 12.12.2013 that yellow-orange precipitations have been observed in batch Y260 in individual cases and therefore a precautionary recall is being carried out. This…
Replacement
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Medicines
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20/11/2013
The marketing authorization holder informed its supplied customers in a letter dated November 20, 2013, that the above-mentioned batches would be recalled from the market because values for the parameter particle size outside the approved…
Medicines
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19/11/2013
The company responsible for distribution, sigma-tau ArzneimittelGmbH, 40212 Düsseldorf, Germany, informed its supplied customers on November 15, 2013, that individual containers of the above-mentioned batches may have fine cracks that may lead to…
Recall
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Medicines
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12/11/2013
Due to a possible quality defect, the companies Sigma-Tau Arzneimittel GmbH and Sigma-Tau Rare Diseases S.A. have decided to recall the above mentioned batches of Oncaspar® Injection Solution.Both companies have been informed by the manufacturer of…
Recall
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Medicines
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11/11/2013
Due to a technical defect, there is a possibility in a small number of Jext epinephrine auto-injectors that the epinephrine is not correctly applied to the muscle when the auto-injector is triggered.
Recall
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Medicines
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08/11/2013
In a small number (0.04% corresponds to 4/10,000) of Jext® pre-filled pens, the adrenaline injection may not be carried out in case of need due to a technical defect. The affected batches will therefore be replaced immediately. To ensure immediate…
Replacement
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Medicines
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25/10/2013
Due to a manufacturing problem during the filling of the cartridges, individual products of the above mentioned batches of "NovoMix® 30 FLexPen®" may have an insulin content that is too high or too low. According to information from the Danish…