{
  "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": "Orlando",
      "state": "FL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA076749"
        ],
        "brand_name": [
          "IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE"
        ],
        "generic_name": [
          "IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE"
        ],
        "manufacturer_name": [
          "Nephron Pharmaceuticals Corporation"
        ],
        "product_ndc": [
          "0487-0201"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "RESPIRATORY (INHALATION)"
        ],
        "substance_name": [
          "ALBUTEROL SULFATE",
          "IPRATROPIUM BROMIDE"
        ],
        "rxcui": [
          "1437702"
        ],
        "spl_id": [
          "32473735-b131-709c-e063-6294a90afde8"
        ],
        "spl_set_id": [
          "ae35ec1f-526a-49bf-8262-c50e40190d1f"
        ],
        "package_ndc": [
          "0487-0201-01",
          "0487-0201-02",
          "0487-0201-03",
          "0487-0201-60"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0304870201018"
        ],
        "unii": [
          "021SEF3731",
          "J697UZ2A9J"
        ]
      },
      "product_type": "Drugs",
      "event_id": "72099",
      "recalling_firm": "Nephron Pharmaceuticals Corp.",
      "address_1": "4121 SW 34th St",
      "address_2": "N/A",
      "postal_code": "32811-6475",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0010-2016",
      "product_description": "Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution, packaged in 30x3 mL Sterile Unit-Dose Vials, a) 30 count (NDC 0487-0201-03) and b) 60 count (NDC 0487-0201-60) vials per carton, Rx only, Nephron Pharmaceutical Corporation, Orlando, FL",
      "product_quantity": "a) 85,248 cartons and b) 35,292 cartons",
      "reason_for_recall": "Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process",
      "recall_initiation_date": "20150821",
      "center_classification_date": "20151009",
      "termination_date": "20170210",
      "report_date": "20151021",
      "code_info": "a) Lot D4E20A, exp 3/2016 and b) Lot D4C21A, exp 3/2016"
    }
  ]
}