Official announcements
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Recall
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Medicines
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05/09/2012
The parallel distributor, HAEMATO PHARM AG; has informed its supplied customers by letter dated 5.9.2012 that the batches placed on the market by him are recalled, because tablets were found which are light blue and have "GILEAD" as tablet embossing.…
Replacement
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Medicines
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27/08/2012
The marketing authorization holder informed its supplied customers in a letter dated August 27, 2012, that in the course of stability tests at the manufacturer Ben Venue Laboratories, Ohio, USA, an overfill was detected in a single dry-stone ampoule…
Replacement
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Medicines
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13/08/2012
The distribution partner sanofi-aventis GmbH Austria informed its supplied customers by letter dated August 13, 2012, that aggregates above the specification limit of 5% occurred after reconstitution of reserve samples of a batch sold in the USA. As…
Medicines
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08/08/2012
Misleading wording in package insert, see related file.
Medicines
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06/08/2012
Packaged finished product batches as of May 2011 contain incorrect information in the package insert, see associated file.
Recall
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Medicines
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13/07/2012
The marketing authorization holder informed its customers by letters dated July 10 and 13, 2012, that the patient-specific batches could have an elevated protein-nitrogen content and that the manufacturer could not rule out the possibility that the…
Recall
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Medicines
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04/07/2012
The marketing authorization holder informed its supplied customers in a letter dated July 2, 2012, that quality deviations were detected in current batches during stability tests. Therefore, as a precautionary measure, the delivery will be stopped…
Recall
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Medicines
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29/06/2012
The marketing authorization holder informed its supplied customers by letter dated 28.06.2012 that the transport carton of batch A010816 is labeled with the strength "Propofol ratiopharm 10 mg/ml emulsion for injection or infusion" (500 mg/50 ml),…
Safety warnings
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Medicines
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05/06/2012
Recently, a quality defect was identified during further development of the product, according to which the epinephrine solution is not delivered or is delivered insufficiently in the event of an anaphylactic emergency.
Recall
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Medicines
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04/06/2012
The distribution company has informed its supplied customers in a letter dated 01.06.2012 that there is a potential problem with the dispensing time and dispensing volume after the autoinjector has been triggered. This problem has arisen during the…