{
  "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": "Terminated",
      "city": "Weston",
      "state": "FL",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA077954"
        ],
        "brand_name": [
          "AZELASTINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "AZELASTINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Apotex Corp."
        ],
        "product_ndc": [
          "60505-0833"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "NASAL"
        ],
        "substance_name": [
          "AZELASTINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1797867"
        ],
        "spl_id": [
          "6ace9d74-df2e-8b53-9bc8-72a794f3a21a"
        ],
        "spl_set_id": [
          "4f58c203-f649-a18e-aaf3-70b0797652f4"
        ],
        "package_ndc": [
          "60505-0833-5"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "0L591QR10I"
        ]
      },
      "product_type": "Drugs",
      "event_id": "62930",
      "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 and Puerto Rico",
      "recall_number": "D-1667-2012",
      "product_description": "Azelastine HCl Nasal Solution, 0.1 %, 137 mcg/spray, 30 mL bottle (200 Metered Sprays), Rx only, Mfg by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, NDC 60505-0833-5.",
      "product_quantity": "963,407 bottles",
      "reason_for_recall": "CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.",
      "recall_initiation_date": "20110615",
      "center_classification_date": "20120829",
      "termination_date": "20120918",
      "report_date": "20120905",
      "code_info": "Lot #: JK9130, JM0925, Exp 05/12; JN6514, Exp 07/12; JN1125, JN1127, Exp 08/12; JR5780, JR5782, Exp 12/12."
    }
  ]
}