Official announcements
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.