{"recall":{"id":"fda-drug-99510","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Liebel-Flarsheim Company LLC recalls Optiray Imaging Bulk Package-350","firm":"Liebel-Flarsheim Company LLC","date":"2026-07-31","reported":"2026-08-19","status":"Ongoing","classification":"Class I","products":[{"name":"Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose Vial, Rx only, Sterile Solution, Manufactured by: Liebel-Flarsheim Company LLC, Raleigh, NC 27616, Made in USA, NDC 0019-1333-65.","code":"Lot # 25ZF3670, Exp Date: May 31, 2027.","quantity":"3,486 500mL-vials","number":"D-0773-2026","classification":"Class I"}],"reason":"Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.","hazard":"FDA Class I: a reasonable probability that use or exposure will cause serious adverse health consequences or death (FDA definition).","affected":"Distributed Nationwide in the US and Mexico.","nationwide":true,"states":[],"units":"3,486 500mL-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=99510","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"e134ef12a2e158da","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=99510","record":[{"status":"Ongoing","city":"Raleigh","state":"NC","country":"United States","classification":"Class I","openfda":{"application_number":["NDA020923"],"brand_name":["OPTIRAY"],"generic_name":["IOVERSOL"],"manufacturer_name":["Liebel-Flarsheim Company LLC"],"product_ndc":["0019-1323","0019-1333","0019-1332"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["INTRA-ARTERIAL","INTRAVENOUS"],"substance_name":["IOVERSOL"],"spl_id":["471b778f-d9cc-ff10-e063-6394a90a27c9"],"spl_set_id":["cd718d1c-f813-4114-a50d-c744ff7eb1bf"],"package_ndc":["0019-1333-65","0019-1323-65","0019-1332-65"],"is_original_packager":[true],"upc":["0300191332653","0300191323651","0300191333650"],"nui":["N0000180185","N0000010258"],"pharm_class_epc":["Radiographic Contrast Agent [EPC]"],"pharm_class_moa":["X-Ray Contrast Activity [MoA]"],"unii":["N3RIB7X24K"]},"product_type":"Drugs","event_id":"99510","recalling_firm":"Liebel-Flarsheim Company LLC","address_1":"8800 Durant Rd","address_2":"","postal_code":"27616-3104","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"Distributed Nationwide in the US and Mexico.","recall_number":"D-0773-2026","product_description":"Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose Vial, Rx only, Sterile Solution, Manufactured by: Liebel-Flarsheim Company LLC, Raleigh, NC 27616, Made in USA, NDC 0019-1333-65.","product_quantity":"3,486 500mL-vials","reason_for_recall":"Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.","recall_initiation_date":"20260731","center_classification_date":"20260819","report_date":"20260819","code_info":"Lot # 25ZF3670, Exp Date: May 31, 2027.","more_code_info":""}]}}