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XEN 45 update for clinicians from Allergan
Allergan wanted to provide a follow up from Friday, October 18th regarding the hold on XEN 45. Allergan has reached out to regulatory agencies, and we are working to initiate a voluntary recall of affected lots of XEN 45.
During our inspection process a small number of units in an unreleased XEN 45 lot were observed to have trace amounts of polishing compounds that are used in the needle sleeve manufacturing process.
As a precautionary measure Allergan issued a product hold of XEN 45 while investigating these findings. Allergan is committed to patient safety, and we anticipate that this voluntary recall will begin in the coming days and additional detailed information will be provided.
Allergan will provide further details in the coming weeks on resupplying the market with newly manufactured lots of XEN 45.
Doctors are advised to continue your routine post-operative follow up and report any adverse events to Allergan Product Surveillance. We appreciate your understanding for the inconvenience this has caused you and your patients.