{"recall":{"id":"fda-drug-99703","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"B BRAUN MEDICAL INC recalls 0","firm":"B BRAUN MEDICAL INC","date":"2026-08-19","reported":"2026-09-16","status":"Ongoing","classification":"Class I","products":[{"name":"0.9% Sodium Chloride Injection, USP, 100 mL Partial Fill in 150 mL PAB Container, Sterile, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018 USA, NDC 0264-1800-32.","code":"Lot #: J6B435, J6B444, J6B457, Exp Date: 30APR2027.","quantity":"201,472 total container","number":"D-0869-2026","classification":"Class I"}],"reason":"Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene","hazard":"FDA Class I: a reasonable probability that use or exposure will cause serious adverse health consequences or death (FDA definition).","affected":"Nationwide within the United States","nationwide":true,"states":[],"units":"201,472 total container","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=99703","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"3431d8e28a30fbe9","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=99703","record":[{"status":"Ongoing","city":"Allentown","state":"PA","country":"United States","classification":"Class I","openfda":{"application_number":["NDA017464"],"brand_name":["SODIUM CHLORIDE"],"generic_name":["SODIUM CHLORIDE"],"manufacturer_name":["B. Braun Medical Inc."],"product_ndc":["0264-1800"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["INTRAVENOUS"],"substance_name":["SODIUM CHLORIDE"],"rxcui":["1807630","1807631","1807632"],"spl_id":["7d4ee37f-5016-422c-9f66-e675ae22c46a"],"spl_set_id":["cc14fafd-3dcd-4fc8-bdbd-6f355c375768"],"package_ndc":["0264-1800-36","0264-1800-31","0264-1800-32"],"is_original_packager":[true],"unii":["451W47IQ8X"]},"product_type":"Drugs","event_id":"99703","recalling_firm":"B BRAUN MEDICAL INC","address_1":"861 Marcon Blvd","address_2":"","postal_code":"18109-9577","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Nationwide within the United States","recall_number":"D-0869-2026","product_description":"0.9% Sodium Chloride Injection, USP, 100 mL Partial Fill in 150 mL PAB Container, Sterile, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018 USA, NDC 0264-1800-32.","product_quantity":"201,472 total container","reason_for_recall":"Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene","recall_initiation_date":"20260819","center_classification_date":"20260922","report_date":"20260916","code_info":"Lot #: J6B435, J6B444, J6B457, Exp Date: 30APR2027.","more_code_info":""}]}}