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.

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 the syringe in the above mentioned batch of GlucaGen HypoKit. During investigations based on two…

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, crystallization was detected in some ampoules.

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 potency. Batches that no longer meet the potency specification and batches where there is a risk of the…

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 are recalled. Stability data for these batches indicated a faster than usual decline in potency.…

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 occurred. Since it cannot be ruled out at this time that the reported adverse reactions are related…

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 medicinal product is placed on the market in Austria within the scope of a transfer notification…

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 1A Pharma 10 mg Tablets" are recalled.

The distributor of the marketing authorization holder has informed the customers supplied in the period 04.05.2016 to 19.05.2016 that due to a wrong delivery of batch 117 a batch of "Dorzo-Vision 20 mg/ml Eye Drops" in the presentation of the German marketing authorization was placed on the market in Austria. The Austrian distribution company has…

The marketing authorization holder informed its supplied customers in a letter dated June 20, 2016, that a precautionary recall is being carried out due to the potential risk of glass particles in the vials.