{
  "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": "Ongoing",
      "city": "Naples",
      "state": "FL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA216075"
        ],
        "brand_name": [
          "GANIRELIX ACETATE"
        ],
        "generic_name": [
          "GANIRELIX ACETATE"
        ],
        "manufacturer_name": [
          "Lupin Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "70748-274"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "GANIRELIX ACETATE"
        ],
        "rxcui": [
          "855200"
        ],
        "spl_id": [
          "c0fdd470-a16f-41c4-9bfa-4240b6ff67e7"
        ],
        "spl_set_id": [
          "e50888ef-5e66-4b15-bdc3-2f6794f09246"
        ],
        "package_ndc": [
          "70748-274-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0370748274019"
        ],
        "unii": [
          "56U7906FQW"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97990",
      "recalling_firm": "Lupin Pharmaceuticals Inc.",
      "address_1": "5801 Pelican Bay Blvd",
      "address_2": "Suite 500",
      "postal_code": "34108-2755",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "FL, MA, MI & OH",
      "recall_number": "D-0220-2026",
      "product_description": "Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' needle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by: Lupin Limited, Nagpur - 441108, INDIA, NDC 70748-274-01",
      "product_quantity": "32736 vials",
      "reason_for_recall": "Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.",
      "recall_initiation_date": "20251113",
      "center_classification_date": "20251208",
      "report_date": "20251217",
      "code_info": "Lot #: WB00006, Exp 12/31/2026",
      "more_code_info": ""
    }
  ]
}