A Class II recall of Kalbitor (ecallantide) was initiated on March 17, 2017. The recall involved Kalbitor 10mg/mL, packaged in 3 vials per carton, Rx only, manufactured by Dynax Corp. in Burlington, MA, under NDC 47783-101-01.
The reason listed for the recall was the presence of particulate matter identified as glass. Shire was named as the recalling firm for this action.
FDA records classify this recall as Class II, a specific regulatory classification for this type of action. The recall status is listed as terminated according to the available record.
This information reflects the details contained in the FDA recall record identified as D-0625-2017. No additional details about distribution scope or affected lots were provided in the source record. Readers should refer to the compound overview for further context on ecallantide.