{
  "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": "East Windsor",
      "state": "NJ",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "ANDA206589"
        ],
        "brand_name": [
          "POLYMYXIN B"
        ],
        "generic_name": [
          "POLYMYXIN B"
        ],
        "manufacturer_name": [
          "Eugia US LLC"
        ],
        "product_ndc": [
          "55150-234"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRATHECAL",
          "INTRAVENOUS",
          "OPHTHALMIC"
        ],
        "substance_name": [
          "POLYMYXIN B SULFATE"
        ],
        "rxcui": [
          "204509"
        ],
        "spl_id": [
          "097fa44b-506b-4ee0-9f64-4b560c3ed41c"
        ],
        "spl_set_id": [
          "a974c557-e88f-451b-a1bd-d2c656be226e"
        ],
        "package_ndc": [
          "55150-234-10"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0355150234103"
        ],
        "unii": [
          "19371312D4"
        ]
      },
      "product_type": "Drugs",
      "event_id": "89457",
      "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": "Nationwide in the US",
      "recall_number": "D-0556-2022",
      "product_description": "Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in 10 vials per carton, Sterile, Rx Only, Distributed by: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-234-10",
      "product_quantity": "35,520 vials",
      "reason_for_recall": "Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot",
      "recall_initiation_date": "20220126",
      "center_classification_date": "20220210",
      "termination_date": "20240820",
      "report_date": "20220216",
      "code_info": "Lot CPB200013, exp 9/2022"
    }
  ]
}