MHRA has issued an alert that specific batches of our products containing gentamicin have an increased level of histamine. This is due to the fact that the supplier of gentamicin sulphate, API, has informed MHRA that they have found an increased level of histamine in one of its production lots. This information was shared with us by the MHRA.
The FAQs, below will hopefully answer your questions, but if further information is needed please do not hesitate to contact us.
What does the alert from MHRA mean?
The alert is a precautionary measure, not a recall. Following reports on elevated histamine levels in certain batches from the manufacturer of gentamicin, the MHRA decided to send out an alert as a precautionary measure.
What is histamine?
Histamine is a natural component involved in the implantation process.
Histamine is also an impurity normally found in the gentamicin raw material in low levels due to the manufacturing process.
Is the gentamicin used in other products and if so, how are they affected by the elevated histamine?
Yes, the gentamicin is also used in drugs for infusion. MHRA reports that a recall is not considered appropriate.
Does this have an impact on embryos or patient treatment?
To the best of our knowledge, there is no evidence that the increased level of histamine impacts embryo development. The MHRA states that “the risks, if any, from the increased histamine levels could not be determined from the available scientific literature”. In terms of risks to patients, the level of histamine is still extremely low and some 13 million times lower than that used in histamine allergy testing.
The products containing gentamicin with elevated histamine levels have been sold globally for more than 1 year with no complaints related to immune or allergy responses.
Why were customers not told prior to the MHRA announcement?
The MHRA requested that we do NOT contact customers before they issued the alert. We have been actively working with the MHRA to support their investigation on elevated histamine in IVF products, while they also sought the opinion of relevant professional bodies and experts.
What do I do if I have further questions?
Please contact your Account Manager or Customer Service for your market.
How do I know if I have used affected batches or still have affected batches in my inventory?
Please contact Customer Service.
Should I return products from affected batches?
The MHRA has not issued a recall. However, if you have issues regarding usage of these products, please contact your local Customer Service to discuss substituting products. There are also no recalls outside the UK, and no agency or regulatory body recommending the return of these products. To the best of our knowledge, there is no evidence that the increased level of histamine impacts embryo development.