This evening we got word from the NUCDF that there has been a recall on specific lots of Buphenyl. The recall affects lot numbers:
3272.059, 3272.060, 3272.061
On the National Urea Cycle Disorders Facebook page this message was posted from the Director of the NUCDF, Cynthia Le Mons.
“According to the recall, made with the knowledge of the FDA, “Recent tests show that bottles from these lots could present a 3-9% under dosing to the patient.” I would advise that if you have been using Buphenyl Powder from one of these lot numbers, report any signs of elevated ammonia or instability to your metabolic physician right away.”
We contacted our genetics team and the pharmacist at John’s Hopkins. Because Corrigan’s monthly dose is smaller than the manufacturer’s bottle size they transfer his Buphenyl to standard prescription containers for shipping. Therefore, we were unable to check our bottle for lot numbers and our pharmacist is unable to tell us if any powder sent to us was from one of the affected lots of Buphenyl. They did have containers of the affected lot on the shelf, which have now been pulled, and are sending us a new batch on Monday from batches not recalled.
Corrigan is wonderfully stable and has had some learning-soaked days recently. I am not concerned that his health has been compromised due to this recall though, as I am sure you understand, I will be hyper-vigilant this weekend watching him for signs of hyperammonemia. I sincerely hope that no UCD patient has been negatively affected by this recall and that it will all be handled quickly and that something like this does not happen again.
It is heartening to realize that in order to catch the underdosing there has been some quality control testing being done. When there is only one choice (for now!) of medicine to keep our child alive we have to put our absolute trust in the manufacturer of that drug. This has been quite the shock to many of us in the UCD community but we are thankful for the immediate action of the NUCDF who made the alert as soon as they found out the information and has worked tirelessly, over the last few hours, to contact as many families as possible about this recall.
I do realize that Facebook may not be everyone’s cup of tea but if you are reading this blog and are not a member of Facebook I would encourage you to join, if for no other reason, than to join the NUCDF Facebook page. The information was disseminated so rapidly through the group alert and the families are able to communicate instantly with each other in times of crisis like this…and we are all there for each other in other times as well, good and bad, it is social networking as it is meant to be. We may not all be able to drive across town for a UCD support group meeting but we can all log in, check in on each other, and give each other the love and support that we need when times are tough.
Best wishes for a wonderful weekend!