{"recall":{"id":"fda-drug-99678","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Baxter Healthcare Corporation recalls 0","firm":"Baxter Healthcare Corporation","date":"2026-08-17","reported":"2026-09-09","status":"Ongoing","classification":"Class I","products":[{"name":"0.9% Sodium Chloride Injection USP 500 mL, VIAFLEX Plastic Containers, with 24 units per case. Baxter Healthcare Corporation, Deerfield, IL, 60015, USA, Made in USA, NDC 0338-0049-03","code":"Lot: Y495523, Y495523A, Exp 31-Oct-2027","quantity":"145,464 500mL bags","number":"D-0849-2026","classification":"Class I"}],"reason":"Presence of particulate matter: Particulates identified as fiberglass","hazard":"FDA Class I: a reasonable probability that use or exposure will cause serious adverse health consequences or death (FDA definition).","affected":"Natonwide in the USA","nationwide":false,"states":[],"units":"145,464 500mL 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=99678","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"4a0b1d271167bd46","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=99678","record":[{"status":"Ongoing","city":"Deerfield","state":"IL","country":"United States","classification":"Class I","openfda":{"application_number":["NDA018016"],"brand_name":["SODIUM CHLORIDE"],"generic_name":["SODIUM CHLORIDE"],"manufacturer_name":["Baxter Healthcare Corporation"],"product_ndc":["0338-0043","0338-0049"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["INTRAVENOUS"],"substance_name":["SODIUM CHLORIDE"],"rxcui":["1807551","1807552","1807627","1807630","1807631","1807632","1807633","1807634","1807639"],"spl_id":["b2052b49-cb90-45d6-b538-f3274f5b46de"],"spl_set_id":["f55bd888-5e01-474d-871b-24654c070178"],"package_ndc":["0338-0049-01","0338-0049-02","0338-0049-03","0338-0049-04","0338-0049-10","0338-0049-41","0338-0049-11","0338-0049-31","0338-0049-48","0338-0049-18","0338-0049-38","0338-0043-03","0338-0043-04"],"is_original_packager":[true],"unii":["451W47IQ8X"]},"product_type":"Drugs","event_id":"99678","recalling_firm":"Baxter Healthcare Corporation","address_1":"1 Baxter Pkwy","address_2":"N/A","postal_code":"60015-4625","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Natonwide in the USA","recall_number":"D-0849-2026","product_description":"0.9% Sodium Chloride Injection USP 500 mL, VIAFLEX Plastic Containers, with 24 units per case. Baxter Healthcare Corporation, Deerfield, IL, 60015, USA, Made in USA, NDC 0338-0049-03","product_quantity":"145,464 500mL bags","reason_for_recall":"Presence of particulate matter: Particulates identified as fiberglass","recall_initiation_date":"20260817","center_classification_date":"20260915","report_date":"20260909","code_info":"Lot: Y495523, Y495523A, Exp 31-Oct-2027","more_code_info":""}]}}