{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-07-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Durham",
      "state": "NC",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA211961"
        ],
        "brand_name": [
          "DAPTOMYCIN"
        ],
        "generic_name": [
          "DAPTOMYCIN"
        ],
        "manufacturer_name": [
          "Accord Healthcare Inc."
        ],
        "product_ndc": [
          "16729-435"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "DAPTOMYCIN"
        ],
        "rxcui": [
          "403920"
        ],
        "spl_id": [
          "40bc0f77-d6a8-2765-e063-6294a90a800a"
        ],
        "spl_set_id": [
          "956b068f-5958-49eb-9c9f-3b6e324e77d2"
        ],
        "package_ndc": [
          "16729-435-05"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0316729435055",
          "316729435055"
        ],
        "nui": [
          "N0000175509",
          "M0519359"
        ],
        "pharm_class_epc": [
          "Lipopeptide Antibacterial [EPC]"
        ],
        "pharm_class_cs": [
          "Lipopeptides [CS]"
        ],
        "unii": [
          "NWQ5N31VKK"
        ]
      },
      "product_type": "Drugs",
      "event_id": "91657",
      "recalling_firm": "Accord Healthcare, Inc.",
      "address_1": "1009 Slater Rd Ste 210B",
      "address_2": "N/A",
      "postal_code": "27703-8446",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "United States including Puerto Rico and Canada",
      "recall_number": "D-0382-2023",
      "product_description": "Daptomycin for Injection 500 mg per vial, Single-dose vial, Rx only, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. NDC 16729-435-05 UPC 3 16729 43505 5.",
      "product_quantity": "228,760 vials",
      "reason_for_recall": "CGMP Deviations: recalling drug products following an FDA inspection.",
      "recall_initiation_date": "20230207",
      "center_classification_date": "20230302",
      "termination_date": "20240422",
      "report_date": "20230308",
      "code_info": "Batches: R2101282, Exp. Date 9/30/2023; R2101600,Exp. Date 11/30/2024; R2200002, R2200028, R2200116, R2200142, R2200152, Exp. Date 12/31/2024; R2200165, R2200190, Exp. Date 1/31/2025; R2201042, Exp. Date 7/31/2025;",
      "more_code_info": ""
    }
  ]
}