{
  "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": "Collegeville",
      "state": "PA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA212046"
        ],
        "brand_name": [
          "DIHYDROERGOTAMINE MESYLATE"
        ],
        "generic_name": [
          "DIHYDROERGOTAMINE MESYLATE"
        ],
        "manufacturer_name": [
          "Provepharm Inc."
        ],
        "product_ndc": [
          "81284-411"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS",
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "DIHYDROERGOTAMINE MESYLATE"
        ],
        "rxcui": [
          "861672"
        ],
        "spl_id": [
          "c3c6ccb7-6054-426c-8a56-d3c29dac13e2"
        ],
        "spl_set_id": [
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        ],
        "package_ndc": [
          "81284-411-00",
          "81284-411-05",
          "81284-411-10"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0381284411059"
        ],
        "unii": [
          "81AXN7R2QT"
        ]
      },
      "product_type": "Drugs",
      "event_id": "95772",
      "recalling_firm": "Provepharm Inc.",
      "address_1": "100 Springhouse Dr Ste 105",
      "address_2": "",
      "postal_code": "19426-4709",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0150-2025",
      "product_description": "Dihydroergotamine Mesylate Injection, solution for injection, USP, 1 mg/mL Ampules, Rx Only, Distributed by: Provepharm Inc. 100 Springhouse Drive Suite 105, Collegeville, PA 19426, NDC 81284-411-05",
      "product_quantity": "2160 packs/5 ampules per pack = 10,800 ampules",
      "reason_for_recall": "Discoloration",
      "recall_initiation_date": "20241122",
      "center_classification_date": "20241216",
      "report_date": "20241225",
      "code_info": "Lot #: F9026F01, F9026F02, Exp. Date 12/2025",
      "more_code_info": ""
    }
  ]
}