Safety Alert Or Field Safety Notices for In vitro fertilisation (IVF) and assisted reproduction technologies (ART) products

Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.

MHRA was made aware by the supplier of gentamicin sulphate API, used in the manufacture of IVF media and associated products, that some batches contained higher than expected levels of histamine due to a change in supplier. It should be noted that histamine is an impurity normally found in gentamicin in low levels because of the manufacturing process.MHRA and the Human Fertilisation & Embryology Authority (HFEA) have worked together to determine whether any risk may have occurred while using affected products in IVF procedures. This included getting advice from experts at the Association of Clinical Embryologists (ACE) and an expert in immunology. The risks, if any, from the increased histamine levels could not be determined from the available scientific literature, therefore this MDA has been published to ensure users are aware of the issue, so they can contact the manufacturer, HFEA, or ACE if they have any concerns.Affected products (all batches) were manufactured from 07/11/2016 to 30/10/2017.Products still within their expiry date were distributed from 07/04/2017 to 18/10/2017.