{"recall":{"id":"fda-drug-99220","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"ONESOURCE SPECIALTY PHARMA LIMITED recalls Methohexital Sodium for Injection","firm":"ONESOURCE SPECIALTY PHARMA LIMITED","date":"2026-06-07","reported":"2026-07-15","status":"Ongoing","classification":"Class II","products":[{"name":"Methohexital Sodium for Injection, USP 500 mg Multiple Dose Vial, Rx Only, Manufactured by: OneSource Specialty, Pharma Limited, Bengaluru - 561 203, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-893-31","code":"Lot #: 7000612A, Exp. Date 1/2028","quantity":"4284 vials","number":"D-0662-2026","classification":"Class II"}],"reason":"Failed Impurities/Degradation Specifications","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Nationwide within the United States","nationwide":true,"states":[],"units":"4284 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=99220","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"79406b5448016910","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=99220","record":[{"status":"Ongoing","city":"Bengaluru","state":"N/A","country":"India","classification":"Class II","openfda":{"application_number":["ANDA215488"],"brand_name":["METHOHEXITAL SODIUM"],"generic_name":["METHOHEXITAL SODIUM"],"manufacturer_name":["Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc."],"product_ndc":["23155-893"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["INTRAMUSCULAR","INTRAVENOUS","RECTAL"],"substance_name":["METHOHEXITAL SODIUM"],"rxcui":["1244233"],"spl_id":["8dd0a3ad-e10f-4877-84f2-9a39960e534d"],"spl_set_id":["f76d4ab9-2f6c-420b-afec-b9cdfdc083ce"],"package_ndc":["23155-893-31"],"is_original_packager":[true],"upc":["0323155893311","0011100004492"],"unii":["60200PNZ7Q"]},"product_type":"Drugs","event_id":"99220","recalling_firm":"ONESOURCE SPECIALTY PHARMA LIMITED","address_1":"Plot No.: 2-D1, Obadenahalli Industrial Area, Doddaballapura","address_2":"3rd Phase; Kasa, Doddaballapura Taluk","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Nationwide within the United States","recall_number":"D-0662-2026","product_description":"Methohexital Sodium for Injection, USP 500 mg Multiple Dose Vial, Rx Only, Manufactured by: OneSource Specialty, Pharma Limited, Bengaluru - 561 203, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-893-31","product_quantity":"4284 vials","reason_for_recall":"Failed Impurities/Degradation Specifications","recall_initiation_date":"20260607","center_classification_date":"20260707","report_date":"20260715","code_info":"Lot #: 7000612A, Exp. Date 1/2028"}]}}