Direct Healthcare Professional Communication (DHPC) on Amiodaron-hameln 50 mg/ml Concentrate for Solution for Injection/Infusion: visual inspection required due to possible crystallization
2021.06.17
Active substance: amiodarone
The company Hameln Pharma GmbH would like to inform that there is an increased potential for crystallization in ampoules. The cause of this increased potential is currently under investigation and the product quality is closely monitored by the company. Before use, visually inspect the sterile concentrate for clarity, particulate matter, discoloration and damage to the container. The solution should only be used if it is clear and the vessel is undamaged and intact.
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