{"recall":{"id":"fda-drug-99204","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Asclemed USA Inc. recalls 2 products","firm":"Asclemed USA Inc.","date":"2026-06-08","reported":"2026-07-08","status":"Ongoing","classification":"Class II","products":[{"name":"Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 76420-715-01.","code":"Lot #: AE3102, 121924X2, 022525X4, 033125X1, 030426X2, 033125X2, 041725X3, 061225X1, 072225X3, 080525X6, 080525X7, 080525X8, 091225X1, 100225X2, 100625X1, 122225X4, 010626X3, 041326X4, Exp 11/30/2026; AE5052, 041426X2, 041726X1, 051826X2, Exp 04/30/2028.","quantity":"N/A","number":"D-0658-2026","classification":"Class II"},{"name":"Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 85766-187-01.","code":"Lot #: AE3102, 031926L01, 032026A01, Exp 11/30/2026; AE5052, 052026G01, Exp 04/30/2028.","quantity":"N/A","number":"D-0659-2026","classification":"Class II"}],"reason":"Lack of Assurance of Sterility","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"USA Nationwide","nationwide":true,"states":[],"units":"N/A; N/A","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=99204","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"a8fcf7706e4b1c7b","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=99204","record":[{"status":"Ongoing","city":"Torrance","state":"CA","country":"United States","classification":"Class II","openfda":{"brand_name":["ACCUCAINE"],"generic_name":["LIDOCAINE HYDROCHLORIDE"],"manufacturer_name":["Asclemed USA, Inc."],"product_ndc":["76420-715"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["INFILTRATION"],"substance_name":["LIDOCAINE HYDROCHLORIDE"],"spl_id":["02db6c14-f841-85bd-e063-6294a90a3bf9"],"spl_set_id":["584642a8-9bed-4d86-bfaf-99018c180e34"],"package_ndc":["76420-715-01"],"is_original_packager":[true],"unii":["V13007Z41A"]},"product_type":"Drugs","event_id":"99204","recalling_firm":"Asclemed USA Inc.","address_1":"379 Van Ness Ave Ste 1403","address_2":"N/A","postal_code":"90501-7211","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distribution_pattern":"USA Nationwide","recall_number":"D-0658-2026","product_description":"Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 76420-715-01.","product_quantity":"N/A","reason_for_recall":"Lack of Assurance of Sterility","recall_initiation_date":"20260608","center_classification_date":"20260702","report_date":"20260708","code_info":"Lot #: AE3102, 121924X2, 022525X4, 033125X1, 030426X2, 033125X2, 041725X3, 061225X1, 072225X3, 080525X6, 080525X7, 080525X8, 091225X1, 100225X2, 100625X1, 122225X4, 010626X3, 041326X4, Exp 11/30/2026; AE5052, 041426X2, 041726X1, 051826X2, Exp 04/30/2028."},{"status":"Ongoing","city":"Torrance","state":"CA","country":"United States","classification":"Class II","openfda":{"application_number":["ANDA208017"],"brand_name":["LIDOCAINE HYDROCHLORIDE"],"generic_name":["LIDOCAINE HYDROCHLORIDE ANHYDROUS"],"manufacturer_name":["Sportpharm LLC"],"product_ndc":["85766-187"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["EPIDURAL","INFILTRATION","INTRACAUDAL","PERINEURAL"],"substance_name":["LIDOCAINE HYDROCHLORIDE ANHYDROUS"],"rxcui":["1737566"],"spl_id":["4d6e159a-1dbb-c957-e063-6394a90aa5f7"],"spl_set_id":["def640dd-bce2-4c18-9ee1-4a1cd5852e89"],"package_ndc":["85766-187-01","85766-187-25"],"original_packager_product_ndc":["65282-1605"],"unii":["EC2CNF7XFP"]},"product_type":"Drugs","event_id":"99204","recalling_firm":"Asclemed USA Inc.","address_1":"379 Van Ness Ave Ste 1403","address_2":"N/A","postal_code":"90501-7211","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distribution_pattern":"USA Nationwide","recall_number":"D-0659-2026","product_description":"Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 85766-187-01.","product_quantity":"N/A","reason_for_recall":"Lack of Assurance of Sterility","recall_initiation_date":"20260608","center_classification_date":"20260702","report_date":"20260708","code_info":"Lot #: AE3102, 031926L01, 032026A01, Exp 11/30/2026; AE5052, 052026G01, Exp 04/30/2028."}]}}