{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Brentwood",
      "state": "MO",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "NDA019430"
        ],
        "brand_name": [
          "EPIPEN"
        ],
        "generic_name": [
          "EPINEPHRINE"
        ],
        "manufacturer_name": [
          "Viatris Specialty LLC"
        ],
        "product_ndc": [
          "49502-500",
          "49502-501"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR"
        ],
        "substance_name": [
          "EPINEPHRINE"
        ],
        "rxcui": [
          "727316",
          "727347",
          "727386",
          "1870207"
        ],
        "spl_id": [
          "81569d26-e9b3-4c1d-ac34-8a4cf5b4a98b"
        ],
        "spl_set_id": [
          "7560c201-9246-487c-a13b-6295db04274a"
        ],
        "package_ndc": [
          "49502-500-01",
          "49502-500-02",
          "49502-500-92",
          "49502-501-01",
          "49502-501-02",
          "49502-501-92"
        ],
        "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"
        ]
      },
      "product_type": "Drugs",
      "event_id": "76789",
      "recalling_firm": "Meridian Medical Technologies a Pfizer Company",
      "address_1": "2555 Hermelin Dr",
      "address_2": "",
      "postal_code": "63144-2504",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Press Release",
      "distribution_pattern": "Nationwide and Puerto Rico, Argentina, Austria, Australia, Belgium, Chile, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Ireland, Italy, Japan, Latvia, Lithuania, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, Sweden, Switzerland, Taiwan, Thailand,  United Kingdom.  There has been no U.S. government or military distribution.",
      "recall_number": "D-0691-2017",
      "product_description": "EpiPen Jr. 2-Pak (Epinephrine) Auto-Injectors 0.15 mg, Rx only, Manufactured for Mylan Specialty L.P., Morgantown WV 26505 by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company; NDC 49502-500-02 ---- ALSO LABELED OUTSIDE THE US AS:  Epipen Auto-Injector Jr. 0.15 mg -Bright Stock labeled for multiple countries- manufactured for Mylan by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company.",
      "product_quantity": "92,544 2-pak (U.S.); 198,579 syringes (O.U.S.)",
      "reason_for_recall": "Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication",
      "recall_initiation_date": "20170312",
      "center_classification_date": "20170428",
      "report_date": "20170510",
      "code_info": "US  lot 5GN767, expiration April 2017;  lot 5GN773, expiration April 2017;  lot 6GN215, expiration Sep 2017:    INTERNATIONAL  lot 5GR765, expiration March 2017;  lot 5GK771, expiration April 2017;  lot 5ED824, expiration April 2017; and   lot 6ED117, expiration ***",
      "more_code_info": ""
    }
  ]
}