{"schemaVersion":"peptidescanner-evidence-object/v1","objectId":"story:fda-enforcement-d-0884-2022:v1","objectPathId":"fda-enforcement-d-0884-2022-v1","kind":"story-version","urls":{"story":"https://peptidescanner.com/stories/fda-enforcement-d-0884-2022/","json":"https://peptidescanner.com/evidence/v1/objects/fda-enforcement-d-0884-2022-v1.json","markdown":"https://peptidescanner.com/evidence/v1/objects/fda-enforcement-d-0884-2022-v1.md"},"story":{"slug":"fda-enforcement-d-0884-2022","version":1,"domain":"Safety","dateInSource":"2022-05-25","sourceCheckedAt":"2026-08-25","publishedAt":"2026-08-25","peptideSlugs":["dulaglutide"],"peptides":[{"slug":"dulaglutide","url":"https://peptidescanner.com/peptides/dulaglutide/"}]},"claims":[{"id":"headline","text":"FDA enforcement report D-0884-2022","sourceIds":["fda-enforcement-d-0884-2022-4c1bd41f618b"]},{"id":"summary","text":"FDA's dated enforcement report D-0884-2022 lists Class II and source status Completed for Cardinal Health Inc. PeptideScanner connects the report to reviewed application BLA125469 through exact openFDA application-number annotations.","sourceIds":["fda-enforcement-d-0884-2022-4c1bd41f618b"]},{"id":"paragraph-1","text":"FDA's dated enforcement report D-0884-2022 lists Class II and source status Completed for Cardinal Health Inc. PeptideScanner connects the report to reviewed application BLA125469 through exact openFDA application-number annotations.","sourceIds":["fda-enforcement-d-0884-2022-4c1bd41f618b"]},{"id":"paragraph-2","text":"FDA's source-reported reason is: TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions","sourceIds":["fda-enforcement-d-0884-2022-4c1bd41f618b"]},{"id":"paragraph-3","text":"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.","sourceIds":["fda-enforcement-d-0884-2022-4c1bd41f618b"]}],"sources":[{"id":"fda-enforcement-d-0884-2022-4c1bd41f618b","name":"FDA enforcement reports via openFDA","sourceClass":"A","title":"FDA enforcement report D-0884-2022 · Class II · report date 2022-05-25 · source status Completed","url":"https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0884-2022%22&limit=1"}],"correction":{"state":"none"},"boundaries":{"scope":"selected-public-evidence-only","reporting":"PeptideScanner reports the cited safety or enforcement record. It is not an individualized risk assessment or medical recommendation.","unknowns":["Sources outside the selected public PeptideScanner bundle may exist and are not represented by this object.","This object does not determine whether cited records agree, corroborate one another, or establish scientific truth.","This object does not determine safety, efficacy, causality, or suitability for any person."],"methodologyUrl":"https://peptidescanner.com/methodology/","medicalDisclaimerUrl":"https://peptidescanner.com/medical-disclaimer/"},"commitments":{"publicationLedgerSha256":"61a33542f10ec3d83587d3c543f541718ffc4e8d6fa13d5b69ced1ab03a8f0fa","tierARecordSha256":"4c1bd41f618b0d120ec864e519a22d0c1ad4ebfd0ab243baa2d7b2d83873378a"},"integrity":{"algorithm":"sha256","contentSha256":"0f845260d25859469af005e3773e6dbea1ff224e250a021cbfca0d9b4f3c1777"}}
