{
  "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 II",
      "openfda": {
        "application_number": [
          "ANDA077559"
        ],
        "brand_name": [
          "IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE"
        ],
        "generic_name": [
          "IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE"
        ],
        "manufacturer_name": [
          "Cipla USA Inc."
        ],
        "product_ndc": [
          "69097-173"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "RESPIRATORY (INHALATION)"
        ],
        "substance_name": [
          "ALBUTEROL SULFATE",
          "IPRATROPIUM BROMIDE"
        ],
        "rxcui": [
          "1437702"
        ],
        "spl_id": [
          "d98264d7-80fe-445f-ac85-2da23d9c374f"
        ],
        "spl_set_id": [
          "3c64255e-074c-41f8-a344-3686a0685020"
        ],
        "package_ndc": [
          "69097-173-64",
          "69097-173-53"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "021SEF3731",
          "J697UZ2A9J"
        ]
      },
      "product_type": "Drugs",
      "event_id": "94289",
      "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": "USA nationwide.",
      "recall_number": "D-0471-2024",
      "product_description": "Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL unit-dose vials, packaged in carton containing 30 vials ( 6 pouches of 5 - 3 mL vials), Rx only, Manufactured by: Cipla Ltd., Indore SEZ, Pithampur, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-173-53",
      "product_quantity": "59244/3ml FFS packs",
      "reason_for_recall": "Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.",
      "recall_initiation_date": "20240326",
      "center_classification_date": "20240424",
      "termination_date": "20250709",
      "report_date": "20240501",
      "code_info": "Lot # IA30390, Exp 4/30/2025, IA30517, Exp 6/30/ 2025",
      "more_code_info": ""
    }
  ]
}