{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Fort Collins",
      "state": "CO",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA021379"
        ],
        "brand_name": [
          "ELIGARD"
        ],
        "generic_name": [
          "LEUPROLIDE ACETATE"
        ],
        "manufacturer_name": [
          "TOLMAR Inc."
        ],
        "product_ndc": [
          "62935-223",
          "62935-753",
          "62935-303",
          "62935-453"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "SUBCUTANEOUS"
        ],
        "rxcui": [
          "752884",
          "752889",
          "752894",
          "752899",
          "825325",
          "825333",
          "825334",
          "825335"
        ],
        "spl_id": [
          "2bea4c81-66a2-4817-9440-5f5da8dea04a"
        ],
        "spl_set_id": [
          "b78d1919-9dee-44fa-90f9-e0a26d32481d"
        ],
        "package_ndc": [
          "62935-753-75",
          "62935-754-74",
          "62935-755-75",
          "62935-223-05",
          "62935-221-04",
          "62935-224-05",
          "62935-303-30",
          "62935-305-29",
          "62935-304-30",
          "62935-453-45",
          "62935-454-44",
          "62935-455-45"
        ],
        "is_original_packager": [
          true
        ]
      },
      "product_type": "Drugs",
      "event_id": "93044",
      "recalling_firm": "Tolmar, Inc.",
      "address_1": "701 Centre Ave",
      "address_2": "N/A",
      "postal_code": "80526-1843",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the US.",
      "recall_number": "D-1178-2023",
      "product_description": "Eligard (leuprolide acetate) for injectable suspension, 7.5 mg every month, Sterile, Rx Only, Must be reconstituted before use, NDC 62935-753-75, Manufactured by: Tolmar Inc., Fort Collins, CO 80526, For Tolmar Therapeutics Inc., Fort Collins, CO 80526.",
      "product_quantity": "2990 cartons",
      "reason_for_recall": "Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.",
      "recall_initiation_date": "20230912",
      "center_classification_date": "20230927",
      "termination_date": "20241003",
      "report_date": "20231004",
      "code_info": "Lot: 13635A1, Exp. 07/31/2024"
    }
  ]
}