Human medicines
Lomaherpan Fieberblasen - Creme
Recall
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Medicines
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23/08/2019
The marketing authorisation holder informed its customers on August 23, 2019 that below mentioned batch is recalled because the content of the active substance is below specification limits.
Lomaherpan Fieberblasen - Creme
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Ropinaest
Recall
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Medicines
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01/08/2019
The marketing authorisation holder informed its customers on August 1, 2019 that the outer packaging may leak.
Ropinaest
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Elotrace
Recall
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Medicines
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03/07/2019
The marketing authorisation holder informed its customers on July 3, 2019 that below mentioned batch of „Elotrace - Infusionszusatz“ show black visible particles.
Elotrace
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Hydal retard
Recall
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Medicines
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14/05/2019
The marketing authorisation holder informed its customers on May 13, 2019 that overweight capsules may be packed and distributed to the market.
Hydal retard
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NaCl- und Glucoseinfusionslösungen
Recall
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Medicines
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26/04/2019
"MEDIKUS medizintechnische und pharmazeutische Vertriebs GmbH" informed its customers on April 26, 2019 that metallic particles were detected in the infusion bags.
NaCl- und Glucoseinfusionslösungen
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Parkemed
Recall
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Medicines
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05/04/2019
The marketing authorisation holder informed its customers on April 4, 2019 that there is a risk that "Parkemed - Suspension zur oralen Anwendung" will likely contain levels of Lead (Pb) and Lithium (Li) which exceed the Permitted Daily Exposure (PDE) levels.
Parkemed
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Tetraspan, Venofundin
Recall
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Medicines
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11/03/2019
The marketing authorisation holder informed its customers on March 6, 2019 that the marketing of „Tetraspan 60 mg/ml Infusionslösung“ and „Venofundin 60 mg/ml Infusionslösung“ is ceased permanently for economic reasons.
Tetraspan, Venofundin
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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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