{
  "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": "Warren",
      "state": "NJ",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "ANDA209959"
        ],
        "brand_name": [
          "ALBUTEROL SULFATE"
        ],
        "generic_name": [
          "ALBUTEROL SULFATE"
        ],
        "manufacturer_name": [
          "Cipla USA Inc."
        ],
        "product_ndc": [
          "69097-142"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "RESPIRATORY (INHALATION)"
        ],
        "substance_name": [
          "ALBUTEROL SULFATE"
        ],
        "rxcui": [
          "2123111"
        ],
        "spl_id": [
          "135ef57d-f447-45c6-ad56-e4f772dc98ee"
        ],
        "spl_set_id": [
          "c4d6d76a-14b8-411a-8019-e2c923c2c532"
        ],
        "package_ndc": [
          "69097-142-60"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "021SEF3731"
        ]
      },
      "product_type": "Drugs",
      "event_id": "92616",
      "recalling_firm": "Cipla USA, Inc.",
      "address_1": "10 Independence Blvd",
      "address_2": "N/A",
      "postal_code": "07059-2730",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the US",
      "recall_number": "D-0938-2023",
      "product_description": "Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net content 6.7 g canister packaged in a box, Rx only, Manufactured by: Cipla Ltd, Indore SE Z, Pithampur, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ, 07059, NDC 69097-142-60",
      "product_quantity": "278,538 canisters",
      "reason_for_recall": "Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).",
      "recall_initiation_date": "20230627",
      "center_classification_date": "20230721",
      "termination_date": "20250306",
      "report_date": "20230719",
      "code_info": "Lot # IB20045, IB20055, IB20056, IB20057, IB20059, IB20072, Exp Nov. 30, 2023",
      "more_code_info": ""
    }
  ]
}