FDA's dated enforcement report D-0622-2021 lists Class II and source status Terminated for Novo Nordisk Inc. PeptideScanner connects the report to reviewed application NDA022341 through exact openFDA application-number annotations. 1
FDA's source-reported reason is: Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors. 1
This PeptideScanner lane is a bounded, dated FDA enforcement-report snapshot connected through an exact openFDA application-number annotation. It is not a medical alert or complete recall-lifecycle tracker, does not establish current product or recall status, does not identify affected lots, and does not provide medical guidance. 1