{
  "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": "Completed",
      "city": "Brookhaven",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA211483"
        ],
        "brand_name": [
          "METHYLERGONOVINE MALEATE"
        ],
        "generic_name": [
          "METHYLERGONOVINE"
        ],
        "manufacturer_name": [
          "Amneal Pharmaceuticals NY LLC"
        ],
        "product_ndc": [
          "69238-1605"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "METHYLERGONOVINE MALEATE"
        ],
        "rxcui": [
          "996824"
        ],
        "spl_id": [
          "5c53f000-01eb-4042-bdb8-e569609413bf"
        ],
        "spl_set_id": [
          "a7ec8dfe-9b58-4363-a709-c1b72ee67855"
        ],
        "package_ndc": [
          "69238-1605-2",
          "69238-1605-8"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "IR84JPZ1RK"
        ]
      },
      "product_type": "Drugs",
      "event_id": "94286",
      "recalling_firm": "Amneal Pharmaceuticals of New York, LLC",
      "address_1": "50 Horseblock Rd",
      "address_2": "",
      "postal_code": "11719-9509",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide.",
      "recall_number": "D-0477-2024",
      "product_description": "Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC, Bridgewater, NJ 08807, NDC # 69238-1605-2.",
      "product_quantity": "2784 bottles",
      "reason_for_recall": "Failed Dissolution Specifications",
      "recall_initiation_date": "20240325",
      "center_classification_date": "20240429",
      "report_date": "20240508",
      "code_info": "Lot #: BJ01922A, exp. date 03/2024",
      "more_code_info": ""
    }
  ]
}