{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "East Windsor",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "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": "79772",
      "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": "US Nationwide",
      "recall_number": "D-0703-2018",
      "product_description": "Linezolid Injection 600 mg per 300 mL (2 mg/mL) For Intravenous Administration, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for AuroMedics Pharma, LLC, NDC 55150-242-51",
      "product_quantity": "395150 bags",
      "reason_for_recall": "Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap",
      "recall_initiation_date": "20180327",
      "center_classification_date": "20180503",
      "termination_date": "20220218",
      "report_date": "20180509",
      "code_info": "Lot/Batch #'s:    CLZ160001, CLZ160002, CLZ160003, CLZ160004 exp July 2018;     CLZ160005, CLZ160006, CLZ160008, CLZ160009, CLZ160010 and CLZ160012, exp August 2018;     CLZ160013, CLZ160014, CLZ160015, CLZ160016, exp October 2018;     CLZ160017, CLZ160018, CLZ160019, CLZ160021, CLZ160022, CLZ160023, exp November 2018;    CLZ170001, CLZ170002, CLZ170003, CLZ170004, CLZ170005, CLZ170006, exp March 2019;     CLZ170007, CLZ170008, CLZ170009, CLZ170010, exp May 2019;    CLZ170011, CLZ170012, exp June 2019;    CLZ170013, CLZ170014, CLZ170015, CLZ170016, exp, September 2019;    CLZ170017, exp October 2019"
    }
  ]
}