{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Parsippany",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA090589"
        ],
        "brand_name": [
          "EPINEPHRINE"
        ],
        "generic_name": [
          "EPINEPHRINE"
        ],
        "manufacturer_name": [
          "Teva Pharmaceuticals USA, Inc."
        ],
        "product_ndc": [
          "0093-5985",
          "0093-5986"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "EPINEPHRINE"
        ],
        "rxcui": [
          "727316",
          "1870207"
        ],
        "spl_id": [
          "f96bd477-2239-4453-aaa4-e20d16c6e49e"
        ],
        "spl_set_id": [
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        ],
        "package_ndc": [
          "0093-5986-19",
          "0093-5986-27",
          "0093-5985-19",
          "0093-5985-27"
        ],
        "is_original_packager": [
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        ],
        "upc": [
          "0300935985275",
          "0300935986272"
        ],
        "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"
        ]
      },
      "product_type": "Drugs",
      "event_id": "85146",
      "recalling_firm": "Teva Pharmaceuticals USA",
      "address_1": "400 Interpace Pkwy",
      "address_2": "N/A",
      "postal_code": "07054-1120",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Product was distributed to 1 wholesaler who still had all units within their possession and had not shipped or further distributed any of the product.",
      "recall_number": "D-1260-2020",
      "product_description": "Epinephrine Injection USP, 0.3 mg (Auto-Injector), 0.3 mg/ 0.3 mL pre-filled syringe, Rx Only, Manufactured for Teva Pharmaceuticals USA, Inc. North Wales, PA 19454. NDC 0093-5986-27",
      "product_quantity": "600 cartons/2 auto-injector per carton",
      "reason_for_recall": "CGMP Deviations: Precautions taken due to Out-of-specification for trigger force for a non-marketed lot number that shares the same component.",
      "recall_initiation_date": "20200305",
      "center_classification_date": "20200505",
      "termination_date": "20201119",
      "report_date": "20200513",
      "code_info": "Lot # 007F19AA, exp. date 04/2021",
      "more_code_info": ""
    }
  ]
}