{"recall":{"id":"fda-drug-99216","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"ACCORD BIOPHARMA INC recalls IMULDOSA","firm":"ACCORD BIOPHARMA INC","date":"2026-06-10","reported":"2026-07-08","status":"Ongoing","classification":"Class II","products":[{"name":"IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Single dose vial, Manufactured by Accord BioPharma Inc., 8041 Arco corporate Drive, Suite 200, Raleigh, NC 27617, USA, Manufactured at: Catalent Indiana, LLC, 1300 S. Patterson Drive, Bloomington, IN 47403, USA, NDC 69448-019-26.","code":"Lot # 004L24A, Exp Date: 02/19/2027.","quantity":"326 vials","number":"D-0653-2026","classification":"Class II"}],"reason":"Lack of assurance of Sterility:","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide.","nationwide":true,"states":[],"units":"326 vials","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99216","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"8f08c1ec62b1bd2f","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99216","record":[{"status":"Ongoing","city":"Raleigh","state":"NC","country":"United States","classification":"Class II","openfda":{"application_number":["BLA761364"],"brand_name":["IMULDOSA"],"generic_name":["USTEKINUMAB-SRLF"],"manufacturer_name":["Accord BioPharma Inc."],"product_ndc":["69448-017","69448-018","69448-019"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["SUBCUTANEOUS"],"substance_name":["USTEKINUMAB-SRLF"],"rxcui":["2717067","2717074","2717078","2717083","2717085","2717086"],"spl_id":["be75347b-ab5d-4104-b90e-7c7b1f46fbef"],"spl_set_id":["2539a6cf-0fe5-1565-e063-6294a90a3618"],"package_ndc":["69448-018-63","69448-017-63","69448-019-26"],"is_original_packager":[true],"upc":["0369448017637","0369448018634"],"unii":["FU77B4U5Z0"]},"product_type":"Drugs","event_id":"99216","recalling_firm":"ACCORD BIOPHARMA INC","address_1":"8041 Arco Corporate Dr Ste 200","address_2":"N/A","postal_code":"27617-2091","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide.","recall_number":"D-0653-2026","product_description":"IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Single dose vial, Manufactured by Accord BioPharma Inc., 8041 Arco corporate Drive, Suite 200, Raleigh, NC 27617, USA, Manufactured at: Catalent Indiana, LLC, 1300 S. Patterson Drive, Bloomington, IN 47403, USA, NDC 69448-019-26.","product_quantity":"326 vials","reason_for_recall":"Lack of assurance of Sterility:","recall_initiation_date":"20260610","center_classification_date":"20260629","report_date":"20260708","code_info":"Lot # 004L24A, Exp Date: 02/19/2027."}]}}