{"schemaVersion":"peptidescanner-evidence-object/v1","objectId":"story:fda-enforcement-d-1178-2023:v1","objectPathId":"fda-enforcement-d-1178-2023-v1","kind":"story-version","urls":{"story":"https://peptidescanner.com/stories/fda-enforcement-d-1178-2023/","json":"https://peptidescanner.com/evidence/v1/objects/fda-enforcement-d-1178-2023-v1.json","markdown":"https://peptidescanner.com/evidence/v1/objects/fda-enforcement-d-1178-2023-v1.md"},"story":{"slug":"fda-enforcement-d-1178-2023","version":1,"domain":"Safety","dateInSource":"2023-10-04","sourceCheckedAt":"2026-08-25","publishedAt":"2026-08-25","peptideSlugs":["leuprolide"],"peptides":[{"slug":"leuprolide","url":"https://peptidescanner.com/peptides/leuprolide/"}]},"claims":[{"id":"headline","text":"FDA enforcement report D-1178-2023","sourceIds":["fda-enforcement-d-1178-2023-62ec8c01e26e"]},{"id":"summary","text":"FDA's dated enforcement report D-1178-2023 lists Class III and source status Terminated for Tolmar, Inc. PeptideScanner connects the report to reviewed application NDA021379 through exact openFDA application-number annotations.","sourceIds":["fda-enforcement-d-1178-2023-62ec8c01e26e"]},{"id":"paragraph-1","text":"FDA's dated enforcement report D-1178-2023 lists Class III and source status Terminated for Tolmar, Inc. PeptideScanner connects the report to reviewed application NDA021379 through exact openFDA application-number annotations.","sourceIds":["fda-enforcement-d-1178-2023-62ec8c01e26e"]},{"id":"paragraph-2","text":"FDA's source-reported reason is: Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.","sourceIds":["fda-enforcement-d-1178-2023-62ec8c01e26e"]},{"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-1178-2023-62ec8c01e26e"]}],"sources":[{"id":"fda-enforcement-d-1178-2023-62ec8c01e26e","name":"FDA enforcement reports via openFDA","sourceClass":"A","title":"FDA enforcement report D-1178-2023 · Class III · report date 2023-10-04 · source status Terminated","url":"https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-1178-2023%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":"52929b7d1daade5cfd19d2b3da192aa52a4fe28c4f035d62986d588c90af6b46","tierARecordSha256":"62ec8c01e26e07b11d8b1dce2210d8df3b4d34b90b4b81d5dafc1d7f8ccad8a2"},"integrity":{"algorithm":"sha256","contentSha256":"8d1bd706a720e7a3fb563b58e3aeb9d225118ccea076a7c8d38960b6676920a3"}}