{
  "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": "Weston",
      "state": "FL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA076396"
        ],
        "brand_name": [
          "CALCITONIN SALMON"
        ],
        "generic_name": [
          "CALCITONIN SALMON"
        ],
        "manufacturer_name": [
          "Apotex Corp."
        ],
        "product_ndc": [
          "60505-0823"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "NASAL"
        ],
        "substance_name": [
          "CALCITONIN SALMON"
        ],
        "rxcui": [
          "313919"
        ],
        "spl_id": [
          "8171dcb4-228d-74b1-cd95-4abb874d2806"
        ],
        "spl_set_id": [
          "c82eb602-12e1-692b-d660-f8d5b5736b54"
        ],
        "package_ndc": [
          "60505-0823-0",
          "60505-0823-6"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "M0003145",
          "N0000175942"
        ],
        "pharm_class_cs": [
          "Calcitonin [CS]"
        ],
        "pharm_class_epc": [
          "Calcitonin [EPC]"
        ],
        "unii": [
          "7SFC6U2VI5"
        ]
      },
      "product_type": "Drugs",
      "event_id": "92208",
      "recalling_firm": "Apotex Corp.",
      "address_1": "2400 N Commerce Pkwy Ste 400",
      "address_2": "N/A",
      "postal_code": "33326-3253",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide throughout the United States",
      "recall_number": "D-0568-2023",
      "product_description": "Calcitonin Salmon (synthetic origin) Nasal Spray, 2200 USP Calcitonin Salmon Units/mL, 200 USP Calcitonin Salmon Units/spray, 3.7 mL bottle, Rx only, Manufactured by: Apotex Corp., Toronto, Ontario, Canada, M9L 1T9, NDC 60505-0823-6",
      "product_quantity": "82,375 bottles",
      "reason_for_recall": "Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable.",
      "recall_initiation_date": "20230426",
      "center_classification_date": "20230509",
      "report_date": "20230517",
      "code_info": "Lot #: TH5645, Exp. 01/2025"
    }
  ]
}