Official announcements
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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…
Recall
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Medicines
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05/04/2012
The distributor has informed its supplied customers in a letter dated April 5, 2012, that the sterility of the batches listed above can no longer be guaranteed and therefore a recall is being carried out as a precautionary measure.
Recall
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Medicines
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02/04/2012
The marketing authorization holder has informed its supplied customers in a letter dated April 2, 2012, that a microbiological contamination has been detected at the manufacturer during a routine media filling in the production line for ViaSpan and…
Recall
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Medicines
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02/04/2012
The marketing authorization holder has informed its supplied customers by letter dated April 02, 2012, that an internal stability test after 15 months of storage has revealed the occurrence of visual particles. The recall affects all dose forms of…
Recall
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Medicines
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22/03/2012
The marketing authorization holder has informed its supplied customers in a letter dated March 22, 2012, that glass splinters were found in the product vials during routine quality control. Therefore, the above mentioned batches are recalled in…
Replacement
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Medicines
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20/03/2012
The distribution company Novartis Pharma GmbH has informed its supplied customers in a letter dated March 19, 2012, that due to water ingress in the manufacturer's warehouse, a batch of the injection syringes included in the Rabipur vaccine kit has…