Following an FDA inspection, ProRx, a 503B outsourcing facility based in Exton, Pennsylvania, had its second major recall of compounded semaglutide and tirzepatide products.
The recall covers nearly 40,000 vials of compounded semaglutide and tirzepatide due to a “lack of assurance of sterility.” This is on top of a recall last year of over 15,000 vials of compounded semaglutide and tirzepatide for the same reason. That’s tens of thousands of doses of potentially unsafe, non-sterile injectables that made their way into the market – all produced outside FDA-approved manufacturing channels.
As I’ve previously explained, it is unlawful for 503B facilities to compound any semaglutide or tirzepatide products. Yet that’s exactly what’s happening – at scale – and, as the recall underscores, without “assurance of sterility.” But that’s not all that ProRx has been cited for. Earlier this year, FDA sent a warning letter to ProRx for failing to wear gloves, using “non-sterile wipes” in aseptic processing areas, and allowing a “flying insect” into an area used for sterile compounding. This recall is yet another proof point that we cannot continue to allow unlawful compounders to operate unchecked. FDA needs to step up and act now.
The recall covers nearly 40,000 vials of compounded semaglutide and tirzepatide due to a “lack of assurance of sterility.” This is on top of a recall last year of over 15,000 vials of compounded semaglutide and tirzepatide for the same reason. That’s tens of thousands of doses of potentially unsafe, non-sterile injectables that made their way into the market – all produced outside FDA-approved manufacturing channels.
As I’ve previously explained, it is unlawful for 503B facilities to compound any semaglutide or tirzepatide products. Yet that’s exactly what’s happening – at scale – and, as the recall underscores, without “assurance of sterility.” But that’s not all that ProRx has been cited for. Earlier this year, FDA sent a warning letter to ProRx for failing to wear gloves, using “non-sterile wipes” in aseptic processing areas, and allowing a “flying insect” into an area used for sterile compounding. This recall is yet another proof point that we cannot continue to allow unlawful compounders to operate unchecked. FDA needs to step up and act now.
