{
  "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": "Parsippany",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA060304"
        ],
        "brand_name": [
          "NEOMYCIN SULFATE"
        ],
        "generic_name": [
          "NEOMYCIN SULFATE"
        ],
        "manufacturer_name": [
          "Teva Pharmaceuticals USA, Inc."
        ],
        "product_ndc": [
          "0093-1177"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "NEOMYCIN SULFATE"
        ],
        "rxcui": [
          "866042"
        ],
        "spl_id": [
          "18e9e5b7-e08c-445e-86bb-90bc0953eda9"
        ],
        "spl_set_id": [
          "777dbfab-f83e-4738-ae1e-78619a9f82a7"
        ],
        "package_ndc": [
          "0093-1177-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0300931177018"
        ],
        "unii": [
          "057Y626693"
        ]
      },
      "product_type": "Drugs",
      "event_id": "90792",
      "recalling_firm": "Teva Pharmaceuticals USA Inc",
      "address_1": "400 Interpace Pkwy Bldg A",
      "address_2": "",
      "postal_code": "07054-1120",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-1473-2022",
      "product_description": "Neomycin Sulfate Tablets, USP 500 mg , 100-count bottles, Rx only, Distributed by: TEVA PHARMACEUTICALS USA, INC North Wales, PA 19454, NDC 0093-1177-01",
      "product_quantity": "",
      "reason_for_recall": "CGMP Deviations: A foreign matter identified as teflon was found in the Active Pharmaceutical Ingredient (API) used in the manufacture of Neomycin Sulfate Tablets, USP 500 mg.",
      "recall_initiation_date": "20220823",
      "center_classification_date": "20220830",
      "termination_date": "20230907",
      "report_date": "20220907",
      "code_info": "Lot #: 3007830, 3007746, 3007829, Exp. Date 10/2024",
      "more_code_info": ""
    }
  ]
}