{
  "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": [
          "ANDA074880"
        ],
        "brand_name": [
          "ALBUTEROL SULFATE"
        ],
        "generic_name": [
          "ALBUTEROL SULFATE"
        ],
        "manufacturer_name": [
          "Nephron Pharmaceuticals Corporation"
        ],
        "product_ndc": [
          "0487-9501"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "RESPIRATORY (INHALATION)"
        ],
        "substance_name": [
          "ALBUTEROL SULFATE"
        ],
        "rxcui": [
          "630208"
        ],
        "spl_id": [
          "43071d13-87b9-6cff-e063-6394a90aff2e"
        ],
        "spl_set_id": [
          "574824f3-51cc-4b94-9c10-e3204d8b19f8"
        ],
        "package_ndc": [
          "0487-9501-25",
          "0487-9501-03",
          "0487-9501-60",
          "0487-9501-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0304879501003"
        ],
        "unii": [
          "021SEF3731"
        ]
      },
      "product_type": "Drugs",
      "event_id": "66462",
      "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": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Nationwide and Puerto Rico",
      "recall_number": "D-66462-001",
      "product_description": "Albuterol Sulfate Inhalation Solution, 0.083%  2.5 mg/3 mL for Oral Inhalation Only, Rx Only, 25 x 3 mL Sterile Unit-Dose Vials per carton, Manufactured By: Nephron Pharmaceuticals Corporation, Orlando, FL 32811, NDC 0487-9501-25",
      "product_quantity": "689,568 cartons",
      "reason_for_recall": "Lack of Assurance of Sterility: Nephron Pharmaceuticals Corporation conducted a routine periodic aseptic process simulation and discovered bacterial growth in a number of media fill vials, exceeding the allowable limit.",
      "recall_initiation_date": "20131002",
      "center_classification_date": "20131018",
      "termination_date": "20150821",
      "report_date": "20131030",
      "code_info": "Lots #: A3A33A, A3A33B, A3A34A, A3A35A. A3A36A, A3A37A, A3A38A, Exp 06/15; A3A40A, A3A41A, A3A42A, Exp 07/15"
    }
  ]
}