FDA's dated enforcement report D-0404-2026 lists Class II and source status Ongoing for Teva Pharmaceuticals USA, Inc. PeptideScanner connects the report to reviewed application ANDA210317 through exact openFDA application-number annotations. 1
FDA's source-reported reason is: Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer. 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