{
  "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": "East Windsor",
      "state": "NJ",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "ANDA206917"
        ],
        "brand_name": [
          "LINEZOLID"
        ],
        "generic_name": [
          "LINEZOLID"
        ],
        "manufacturer_name": [
          "Eugia US LLC"
        ],
        "product_ndc": [
          "55150-242"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "LINEZOLID"
        ],
        "rxcui": [
          "1662285"
        ],
        "spl_id": [
          "dd9cd434-03f1-4f0d-ad84-c5611f6e5abf"
        ],
        "spl_set_id": [
          "b721756c-3b5e-456d-a2f6-0d8a56cc7f35"
        ],
        "package_ndc": [
          "55150-242-51"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175495",
          "M0361132"
        ],
        "pharm_class_epc": [
          "Oxazolidinone Antibacterial [EPC]"
        ],
        "pharm_class_cs": [
          "Oxazolidinones [CS]"
        ],
        "unii": [
          "ISQ9I6J12J"
        ]
      },
      "product_type": "Drugs",
      "event_id": "78800",
      "recalling_firm": "AuroMedics Pharma LLC",
      "address_1": "279 Princeton Hightstown Rd",
      "address_2": "N/A",
      "postal_code": "08520-1401",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Product was distributed throughout United States.",
      "recall_number": "D-0337-2018",
      "product_description": "Linezolid Injection 600 mg/300 mL (2 mg/mL), 300 mL Single-use, ready-to-use flexible plastic infusion bags in a foil laminate overwrap, Rx only, Mfd in India for: AuroMedics Pharma LLC, Dayton, NJ --- NDC 55150-242-51",
      "product_quantity": "9,050 bags",
      "reason_for_recall": "Presence of Particulate Matter; white particulate matter identified as mold was found in one bag",
      "recall_initiation_date": "20171220",
      "center_classification_date": "20180208",
      "termination_date": "20190624",
      "report_date": "20180214",
      "code_info": "Lot # CLZ160007, Exp August 2018"
    }
  ]
}