{
  "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": [
    {
      "country": "United States",
      "city": "Cranbury",
      "address_1": "270 Prospect Plains Rd",
      "reason_for_recall": "Sun Pharmaceutical is recalling Azelastine HCl Nasal Solution, 0.1% (30 mL Bottle) following a failure to meet the % RSD requirement in the test for Droplet Size during the 6 month long term stability test station",
      "address_2": "",
      "product_quantity": "17554 bottles",
      "code_info": "JKR7706A December 2018  JKR7705A November 2018",
      "center_classification_date": "20180213",
      "distribution_pattern": "Nationwide",
      "state": "NJ",
      "product_description": "Azelastine HCl Nasal Solution (Nasal Spray) 0.1% (137 mcg per spray), 30 mL, Rx only, Distributed by: Sun Pharmaceutical Ind. Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Ind. Ltd. Halol-Baroda Highway, Halol - 389 350, Gujarat, India --- NDC 47335-779-91",
      "report_date": "20180221",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA090423"
        ],
        "brand_name": [
          "AZELASTINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "AZELASTINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
          "47335-779"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "NASAL"
        ],
        "substance_name": [
          "AZELASTINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1797867"
        ],
        "spl_id": [
          "09652cb1-7315-4188-9f36-4e2b50fb764d"
        ],
        "spl_set_id": [
          "305c6dc8-8247-473d-9975-b02903af6d53"
        ],
        "package_ndc": [
          "47335-779-91"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "0L591QR10I"
        ]
      },
      "recalling_firm": "Sun Pharmaceutical Industries, Inc.",
      "recall_number": "D-0417-2018",
      "initial_firm_notification": "Letter",
      "product_type": "Drugs",
      "event_id": "79145",
      "termination_date": "20190311",
      "more_code_info": "",
      "recall_initiation_date": "20180205",
      "postal_code": "08512-3605",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}