{
  "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": "Dublin",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA202496"
        ],
        "brand_name": [
          "IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE"
        ],
        "generic_name": [
          "IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE"
        ],
        "manufacturer_name": [
          "Cipla USA Inc."
        ],
        "product_ndc": [
          "69097-840"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "RESPIRATORY (INHALATION)"
        ],
        "substance_name": [
          "IPRATROPIUM BROMIDE",
          "ALBUTEROL SULFATE"
        ],
        "rxcui": [
          "1437702"
        ],
        "spl_id": [
          "14b7dfcc-b3a8-4027-9544-8d52ec2aacf3"
        ],
        "spl_set_id": [
          "89d59bd9-c826-413c-8ed9-a1521a0c7cc5"
        ],
        "package_ndc": [
          "69097-840-34",
          "69097-840-53",
          "69097-840-87",
          "69097-840-64"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "J697UZ2A9J",
          "021SEF3731"
        ]
      },
      "product_type": "Drugs",
      "event_id": "89450",
      "recalling_firm": "CARDINAL HEALTHCARE",
      "address_1": "7200 Cardinal Pl W",
      "address_2": "",
      "postal_code": "43017-1094",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide USA",
      "recall_number": "D-0161-2024",
      "product_description": "Ipratropium Bromide and Albuterol Sulfate Inhalation Solution (0.5 mg/3 mg per 3 mL), 60 x 3 mL Sterile Unit-Dose Vials (2 pouches of 30 - 3 mL vials each), Manufactured By: The Ritedose Corporation, Columbia, SC 29203; Distributed By: Cipla USA Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-840-64",
      "product_quantity": "2 cartons",
      "reason_for_recall": "CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.",
      "recall_initiation_date": "20220126",
      "center_classification_date": "20231226",
      "termination_date": "20240929",
      "report_date": "20240103",
      "code_info": "Batch 21C56",
      "more_code_info": ""
    }
  ]
}