Human medicines
Vantobra
Recall
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Medicines
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21/02/2019
The marketing authorisation holder informed its customers on February 19, 2019 that the marketing authorisation of „Vantobra 170 mg Lösung für einen Vernebler“ will be withdrawn.
Vantobra
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Sprycel 100 mg Filmtabletten
Recall
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Medicines
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15/02/2019
The parallel distributor „HAEMATO PHARM GmbH“ informed its customers on February 14, 2019 that the supply chain is not fully documented and GDP-guidelines are not met.
Sprycel 100 mg Filmtabletten
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Valsartan / Sartan-containing drugs: Pharmaceutical companies to review manufacturing processes to avoid occurrence of nitrosamine-containing impurities
Safety warnings
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Medicines
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14/02/2019
During the transitional phase, strict limits are already in place for these impurities.
Valsartan / Sartan-containing drugs: Pharmaceutical companies to review manufacturing processes to avoid occurrence of nitrosamine-containing impurities
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Hepa-Merz 5 g / 10 ml infusion solution concentrate
Recall
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Medicines
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28/12/2018
The marketing authorization holder has informed its supplied customers in a letter dated December 27, 2018, that the above-mentioned batch…
Falsification suspicion of parallel-imported "ALIMTA 500 mg powder for the preparation of a concentrate for infusion solution".
Safety warnings
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Medicines
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21/12/2018
No acute danger, all packages available in Austria have already been recalled by BASG.
Falsification suspicion of parallel-imported "ALIMTA 500 mg powder for the preparation of a concentrate for infusion solution".
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Vitamin C - Injection guide
Recall
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Medicines
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18/12/2018
The marketing authorization holder informed its supplied customers in a letter dated December 18, 2018, that follow-up inspections of the finished…
Prednifluid
Recall
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Medicines
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03/12/2018
The marketing authorization holder informed its supplied customers in a letter dated December 3, 2018, that there are increased reports of side…
Valsartan/HCT from Teva B.V.
Recall
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Medicines
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23/11/2018
The marketing authorization holder informed its supplied customers in a letter dated November 23, 2018, that the active ingredient manufacturer Mylan…
Production-related contamination with N-nitrosodiethylamine (NDEA) in the active ingredient valsartan from the manufacturer "Mylan Laboratory Limited".
Safety warnings
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Medicines
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23/11/2018
Recall of certain lots of "Valsartan/HCT ratiopharm 80 mg/12.5 mg Film-Coated Tablets" and "Valsartan/HCT ratiopharm 160 mg/25 mg Film-Coated Tablets" containing valsartan active ingredient manufactured by "Mylan Laboratory Limited".
Production-related contamination with N-nitrosodiethylamine (NDEA) in the active ingredient valsartan from the manufacturer "Mylan Laboratory Limited".
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Novalgin
Recall
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Medicines
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20/11/2018
The marketing authorization holder has informed its supplied customers in a letter dated November 16, 2018, that isolated impurities or contamination…
