{
  "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 I",
      "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": "73118",
      "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 and Puerto Rico",
      "recall_number": "D-0863-2016",
      "product_description": "Metronidazole Injection USP, 500 mg per 100 mL (5 mg/mL), 100mL Sterile Single Dose Container bag, Rx only, Baxter USA, Product Code 2B3421, NDC 0338-1055-48.",
      "product_quantity": "334,560 bags",
      "reason_for_recall": "Presence of Particulate Matter: identified as a cloth fiber.",
      "recall_initiation_date": "20160121",
      "center_classification_date": "20160523",
      "termination_date": "20180226",
      "report_date": "20160601",
      "code_info": "Lot #: P339135, Exp 08/31/2017"
    }
  ]
}