Official announcements
Recall
|
Veterinary Medicines
|
29/09/2016
In a letter dated 19.09.2016, the marketing authorization holder informed its customers that particles had been detected in some bottles. It cannot be ruled out that bottles on the market are also affected, which is why a recall is being carried out. As the product is a veterinary specialty approved in Germany, it can be placed on the market in…
Safety warnings
|
Blood & Tissue
|
27/09/2016
The Federal Office for Public Health Safety was informed by the Hungarian authorities that confirmed human WNV cases (neuroinvasive disease) were recorded in Budapest and in the counties of Pest, Bács-Kiskun, Békés, Borsod-Abaúj- Zemplén, Fejér, Györ-Moson Sopron, Heves, Hajdú-Bihar, Jász-Nagykun-Szolnok, Szabolcs-Szatmár-Bereg and Veszprém.
Safety warnings
|
Blood & Tissue
|
20/09/2016
The Federal Office for Public Health Safety has been informed by the Italian authority that a confirmed human WNV case (neuroinvasive disease) has occurred in the province of Trapani (Region of Sicily). WNV NAT testing is being conducted in this region.
Safety warnings
|
Blood & Tissue
|
20/09/2016
The Federal Office for Public Health Safety has been informed by the Greek authority that another confirmed locally acquired malaria case has been recorded in Greece. No travel activity of the infected person is known.
Recall
|
Medicines
|
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 caused by an unsuitable connecting piece during filling.
Recall
|
Medicines
|
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 it may be microbiologically contaminated with "Burkholderia cepacia". Infected wipes show a light…
Safety warnings
|
Blood & Tissue
|
15/09/2016
The Federal Office for Public Health Safety has been informed by the Italian authority that WNV NAT testing will now be carried out in the provinces of Alessandria and Novara (Piedmont Region) in addition to the regions already announced.
Safety warnings
|
Blood & Tissue
|
08/09/2016
On 31 August 2016 the autonomous Community of Madrid, Spain, reported two cases of infection with Crimean–Congo haemorrhagic fever(CCHF) virus.
Safety warnings
|
Blood & Tissue
|
06/09/2016
The Federal Office for Public Health Safety has been informed by the Italian authority that WNV NAT testing will now be carried out in the province of Vercelli (Piedmont Region) in addition to the regions already announced.
Safety warnings
|
Medicines
|
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.