{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Deerfield",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA018657"
        ],
        "brand_name": [
          "METRONIDAZOLE"
        ],
        "generic_name": [
          "METRONIDAZOLE"
        ],
        "manufacturer_name": [
          "Baxter Healthcare Corporation"
        ],
        "product_ndc": [
          "0338-1055"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "METRONIDAZOLE"
        ],
        "rxcui": [
          "311683"
        ],
        "spl_id": [
          "7841a410-43a9-4c79-acee-b831b42da8a8"
        ],
        "spl_set_id": [
          "d2112f37-5080-4a19-bcc3-6386b49abe1d"
        ],
        "package_ndc": [
          "0338-1055-48"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175435",
          "M0014907"
        ],
        "pharm_class_epc": [
          "Nitroimidazole Antimicrobial [EPC]"
        ],
        "pharm_class_cs": [
          "Nitroimidazoles [CS]"
        ],
        "unii": [
          "140QMO216E"
        ]
      },
      "product_type": "Drugs",
      "event_id": "65288",
      "recalling_firm": "Baxter Healthcare Corp.",
      "address_1": "1 Baxter Pkwy",
      "address_2": "N/A",
      "postal_code": "60015-4625",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide & Puerto Rico",
      "recall_number": "D-629-2013",
      "product_description": "Metronidazole Injection USP, RTU, 500 mg/100mL in Viaflex Plus Container, Baxter, Deerfield, IL 60015, NDC 0338-1055-48",
      "product_quantity": "172,296 units",
      "reason_for_recall": "Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.",
      "recall_initiation_date": "20130521",
      "center_classification_date": "20130628",
      "termination_date": "20150618",
      "report_date": "20130710",
      "code_info": "Lot #: P280123, P280123A, Exp 2/14"
    }
  ]
}