{
  "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": "Terminated",
      "city": "Malvern",
      "state": "PA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA076979"
        ],
        "brand_name": [
          "CALCITONIN SALMON"
        ],
        "generic_name": [
          "CALCITONIN SALMON"
        ],
        "manufacturer_name": [
          "Par Health USA, LLC"
        ],
        "product_ndc": [
          "49884-161"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "NASAL"
        ],
        "substance_name": [
          "CALCITONIN SALMON"
        ],
        "rxcui": [
          "313919"
        ],
        "spl_id": [
          "0f4b56a3-ce50-41b6-985a-270bf416ffef"
        ],
        "spl_set_id": [
          "a6eaedb3-5c96-4859-be43-a48c9c818bc7"
        ],
        "package_ndc": [
          "49884-161-11"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "M0003145",
          "N0000175942"
        ],
        "pharm_class_cs": [
          "Calcitonin [CS]"
        ],
        "pharm_class_epc": [
          "Calcitonin [EPC]"
        ],
        "unii": [
          "7SFC6U2VI5"
        ]
      },
      "product_type": "Drugs",
      "event_id": "91802",
      "recalling_firm": "Endo Pharmaceuticals, Inc.",
      "address_1": "1400 Atwater Dr",
      "address_2": "N/A",
      "postal_code": "19355-8701",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Nationwide in the USA and Puerto Rico",
      "recall_number": "D-0475-2023",
      "product_description": "Calcitonin Salmon Nasal Spray, USP, 2200 International Units per mL corresponding to 200 International Units/spray, 3.7 mL bottle, Rx only, Manufactured by: Par Pharmaceutical, Chestnut Ridge, NY  10977, NDC 49884-161-11.",
      "product_quantity": "372,938 bottles",
      "reason_for_recall": "Failed Impurities/Degradation Specifications and Subpotent Drug: High Out of Specification results for a known and unknown impurity as well as low Out of Specification results for assay.",
      "recall_initiation_date": "20230302",
      "center_classification_date": "20230324",
      "termination_date": "20241108",
      "report_date": "20230405",
      "code_info": "Lot #:  34770301, exp. date Mar-23; 34770401, exp. date May-23; 12981201, exp. date Nov-23; 13037201, exp. date Dec-23; 13037301, 13647801, exp. date Feb-24; 13722101, exp. date Mar-24; 13980101, 13980001, exp. date Apr-24; 14461701, 14461801, exp. date Jul-24; 14706201, exp. date Aug-24; 14935601, exp. date Oct-24; 5500131A, 5500132A, exp. date Mar-25"
    }
  ]
}