{"recall":{"id":"fda-drug-99732","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Golden State Medical Supply Inc. recalls Prasugrel HCI","firm":"Golden State Medical Supply Inc.","date":"2026-08-21","reported":"2026-09-09","status":"Ongoing","classification":"Class II","products":[{"name":"Prasugrel HCI, Tablets, USP, 10mg, 30-count bottle, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC: 51407-445-30.","code":"Lot # GS062298, Exp Date: 09/30/ 2026.","quantity":"6791 30-count bottles","number":"D-0847-2026","classification":"Class II"}],"reason":"Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide.","nationwide":true,"states":[],"units":"6791 30-count bottles","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=99732","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"2860e16a7b361132","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=99732","record":[{"status":"Ongoing","city":"Camarillo","state":"CA","country":"United States","classification":"Class II","openfda":{"application_number":["ANDA205927"],"brand_name":["PRASUGREL"],"generic_name":["PRASUGREL"],"manufacturer_name":["Golden State Medical Supply, Inc."],"product_ndc":["51407-444","51407-445"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"substance_name":["PRASUGREL HYDROCHLORIDE"],"rxcui":["855812","855818"],"spl_id":["20262c39-020c-b649-e063-6294a90a2d9f"],"spl_set_id":["bb78f952-69a5-1620-e053-2a95a90afe97"],"package_ndc":["51407-444-30","51407-445-30"],"original_packager_product_ndc":["0378-5185","0378-5186"],"unii":["G89JQ59I13"]},"product_type":"Drugs","event_id":"99732","recalling_firm":"Golden State Medical Supply Inc.","address_1":"5187 Camino Ruiz","address_2":"N/A","postal_code":"93012-8601","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide.","recall_number":"D-0847-2026","product_description":"Prasugrel HCI, Tablets, USP, 10mg, 30-count bottle, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC: 51407-445-30.","product_quantity":"6791 30-count bottles","reason_for_recall":"Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution","recall_initiation_date":"20260821","center_classification_date":"20260915","report_date":"20260909","code_info":"Lot # GS062298, Exp Date: 09/30/ 2026.","more_code_info":""}]}}