{
  "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": "Melville",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA204200"
        ],
        "brand_name": [
          "ADRENALIN"
        ],
        "generic_name": [
          "EPINEPHRINE",
          "EPINEPRINE"
        ],
        "manufacturer_name": [
          "Par Health USA, LLC",
          "Henry Schein, Inc."
        ],
        "product_ndc": [
          "42023-159",
          "42023-168",
          "0404-9810"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS",
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "EPINEPHRINE"
        ],
        "rxcui": [
          "310132",
          "1490057",
          "1660014",
          "1660016"
        ],
        "spl_id": [
          "373c1f0e-d2e7-40bf-8a39-fdf404fc91df",
          "d61797df-009f-4a42-ba7d-64fff2d7a321"
        ],
        "spl_set_id": [
          "3b7a4364-668d-4eb2-a20c-04adc35aabe4",
          "b293ad8e-7055-4a95-a130-9d7d74f19eab"
        ],
        "package_ndc": [
          "42023-159-01",
          "42023-159-25",
          "42023-168-01",
          "0404-9810-01"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000000209",
          "N0000000245",
          "N0000175552",
          "N0000175555",
          "N0000175570",
          "M0003647"
        ],
        "pharm_class_moa": [
          "Adrenergic alpha-Agonists [MoA]",
          "Adrenergic beta-Agonists [MoA]"
        ],
        "pharm_class_epc": [
          "alpha-Adrenergic Agonist [EPC]",
          "beta-Adrenergic Agonist [EPC]",
          "Catecholamine [EPC]"
        ],
        "pharm_class_cs": [
          "Catecholamines [CS]"
        ],
        "unii": [
          "YKH834O4BH"
        ],
        "original_packager_product_ndc": [
          "42023-159"
        ]
      },
      "product_type": "Drugs",
      "event_id": "93839",
      "recalling_firm": "Henry Schein Inc. and Glove Club HSI Gloves Inc.",
      "address_1": "135 Duryea Rd",
      "address_2": "N/A",
      "postal_code": "11747-3834",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "USA nationwide.",
      "recall_number": "D-0342-2024",
      "product_description": "Adrenalin (epinephrine) Injection 1mg/mL, 1mL single dose vial, Rx only, Packaged By: Henry Schein, Inc., 80 Summit View Lane, Bastian, VA 24314, Original NDC 42023-159-25 Repack NDC 0404-9810-01",
      "product_quantity": "1,099 Single Dose Vials",
      "reason_for_recall": "Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect.",
      "recall_initiation_date": "20240117",
      "center_classification_date": "20240221",
      "report_date": "20240228",
      "code_info": "Original Lot # 64103, exp. date 11/24 Repackaged Lot # 39747, exp. date 01/26"
    }
  ]
}