{"recall":{"id":"fda-drug-99633","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"B BRAUN MEDICAL INC recalls Lactated Ringer's Injection USP","firm":"B BRAUN MEDICAL INC","date":"2026-08-12","reported":"2026-09-02","status":"Ongoing","classification":"Class I","products":[{"name":"Lactated Ringer's Injection USP, 1000 mL EXCEL container, Rx only, L7500, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-00","code":"Lot#: J4H077, Exp 30NOV2026.","quantity":"23,688 bags","number":"D-0832-2026","classification":"Class I"}],"reason":"Presence of Particulate matter.","hazard":"FDA Class I: a reasonable probability that use or exposure will cause serious adverse health consequences or death (FDA definition).","affected":"U.S. Nationwide","nationwide":true,"states":[],"units":"23,688 bags","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=99633","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"98a21e6cab76dd5e","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=99633","record":[{"status":"Ongoing","city":"Allentown","state":"PA","country":"United States","classification":"Class I","openfda":{"application_number":["NDA019632"],"brand_name":["LACTATED RINGERS"],"generic_name":["SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE"],"manufacturer_name":["B. Braun Medical Inc."],"product_ndc":["0264-7750"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["INTRAVENOUS"],"substance_name":["SODIUM CHLORIDE","SODIUM LACTATE","POTASSIUM CHLORIDE","CALCIUM CHLORIDE"],"rxcui":["847630"],"spl_id":["13f7b9a6-d2da-49fe-b7c2-11a4953b2aed"],"spl_set_id":["d3d29c8f-c326-4097-814a-7f4e08c67068"],"package_ndc":["0264-7750-00","0264-7750-10","0264-7750-20"],"is_original_packager":[true],"unii":["451W47IQ8X","TU7HW0W0QT","660YQ98I10","M4I0D6VV5M"]},"product_type":"Drugs","event_id":"99633","recalling_firm":"B BRAUN MEDICAL INC","address_1":"861 Marcon Blvd","address_2":"N/A","postal_code":"18109-9577","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"U.S. Nationwide","recall_number":"D-0832-2026","product_description":"Lactated Ringer's Injection USP, 1000 mL EXCEL container, Rx only, L7500, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-00","product_quantity":"23,688 bags","reason_for_recall":"Presence of Particulate matter.","recall_initiation_date":"20260812","center_classification_date":"20260903","report_date":"20260902","code_info":"Lot#: J4H077, Exp 30NOV2026."}]}}