There’s an EpiPen recall in Australia due to a defect that may make it difficult to activate in an emergency (failure to activate or increased force needed to activate). Two reports have been confirmed of the device failing to activate in a batch of about 80,000 devices.
We all know that the risk of inadequate epinephrine dosage during anaphylaxis is death, and I submit that a risk analysis should result in a massive recall. Remember that with the Auvi-Q/Allerject recall of every device ever sold anywhere, there were NO confirmed reports. My take on that recall is here.
The EpiPens in Australia were manufactured by Meridian Medical Technologies in St. Louis Missouri, USA, and I believe they manufacture EpiPens for distribution world wide. At present, batch numbers 5FA665, 5FA6651, 5FA6652 or 5FA6653 and an expiry of Apr 17 should be exchanged at the pharmacy immediately.
I predict that the recall will migrate world wide. Don’t you think it should, given Sanofi’s handling of the Auvi-Q recall? ….
UPDATE 31 March 2017: As I predicted, Mylan has expanded the recall to now include additional lots distributed in the U.S. and other markets in consultation with the U.S. Food and Drug Administration (FDA). The expanded voluntary recall is being initiated in the U.S. and also will extend to additional markets in Europe, Asia, North and South America and now impacts both the 0.3 mg and 0.15 mg strengths of EpiPen Auto-Injector.
To share this article, please use the buttons below or copy and paste this link: http://blog.onespotallergy.com/2017/03/epipen-recall-should-it-spread-worldwide/
To read the press release regarding the recall, click here.
To read the press release regarding the expanded recall included the affected lot numbers and expiry dates, click here.