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. 1
FDA's source-reported reason is: Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product. 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
What this source can tell us. PeptideScanner is reporting the cited safety or enforcement record. It is not an individualized risk assessment or medical recommendation.