{"recall":{"id":"fda-drug-99564","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"BioSpectra, Inc. recalls Biospectra Tris/Tromethamine","firm":"BioSpectra, Inc.","date":"2026-07-29","reported":"2026-10-14","status":"Ongoing","classification":"Class II","products":[{"name":"Biospectra Tris/Tromethamine, USP, GMP, API Grade, Manufactured at 100 Majestic Way, Bangor, PA 18013, NDC 64173-101-25","code":"Lot#: TRIS -E04-0226-0016; Exp 2/29/28","quantity":"200 kg","number":"D-0012-2027","classification":"Class II"}],"reason":"Failed stability specifications","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"CA","nationwide":false,"states":["CA"],"units":"200 kg","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=99564","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"132ed05a06d21601","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=99564","record":[{"status":"Ongoing","city":"Bangor","state":"PA","country":"United States","classification":"Class II","openfda":{},"product_type":"Drugs","event_id":"99564","recalling_firm":"BioSpectra, Inc.","address_1":"100 Majestic Way","address_2":"N/A","postal_code":"18013-2860","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Telephone","distribution_pattern":"CA","recall_number":"D-0012-2027","product_description":"Biospectra Tris/Tromethamine, USP, GMP, API Grade, Manufactured at 100 Majestic Way, Bangor, PA 18013, NDC 64173-101-25","product_quantity":"200 kg","reason_for_recall":"Failed stability specifications","recall_initiation_date":"20260729","center_classification_date":"20261006","report_date":"20261014","code_info":"Lot#: TRIS -E04-0226-0016; Exp 2/29/28"}]}}