{
  "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": "2026-09-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Shirley",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA072489"
        ],
        "brand_name": [
          "ACETYLCYSTEINE"
        ],
        "generic_name": [
          "ACETYLCYSTEINE"
        ],
        "manufacturer_name": [
          "American Regent, Inc."
        ],
        "product_ndc": [
          "0517-7504",
          "0517-7604",
          "0517-7510",
          "0517-7610",
          "0517-7630"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "RESPIRATORY (INHALATION)"
        ],
        "substance_name": [
          "ACETYLCYSTEINE"
        ],
        "rxcui": [
          "307718",
          "307719"
        ],
        "spl_id": [
          "2bcb9dd3-17f8-439e-a395-aa081c5cc4bf"
        ],
        "spl_set_id": [
          "f56b4087-db48-4fd7-84ec-9c927962b805"
        ],
        "package_ndc": [
          "0517-7504-25",
          "0517-7604-25",
          "0517-7510-03",
          "0517-7610-03",
          "0517-7630-03",
          "0517-7604-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0305177510032",
          "0305177604250",
          "0305177504253",
          "0305177610039"
        ],
        "nui": [
          "N0000175429",
          "N0000175961",
          "N0000008867",
          "N0000175960",
          "N0000175776",
          "N0000175547"
        ],
        "pharm_class_epc": [
          "Antidote [EPC]",
          "Antidote for Acetaminophen Overdose [EPC]",
          "Mucolytic [EPC]"
        ],
        "pharm_class_pe": [
          "Decreased Respiratory Secretion Viscosity [PE]",
          "Increased Glutathione Concentration [PE]"
        ],
        "pharm_class_moa": [
          "Reduction Activity [MoA]"
        ],
        "unii": [
          "WYQ7N0BPYC"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99503",
      "recalling_firm": "American Regent, Inc.",
      "address_1": "5 Ramsay Rd",
      "address_2": "",
      "postal_code": "11967-4701",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Press Release",
      "distribution_pattern": "Nationwide within the U.S",
      "recall_number": "D-0797-2026",
      "product_description": "ACETYLCYSTEINE SOLUTION, USP, 20% (200 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 0517-7604-01), and b) 25x4 mL Vials NOT FOR INJECTION (NDC 0517-7604-25), Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.",
      "product_quantity": "169,200 vials",
      "reason_for_recall": "Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde",
      "recall_initiation_date": "20260724",
      "center_classification_date": "20260826",
      "report_date": "20260826",
      "code_info": "Lot #: 24426, Exp. Date: 11/30/2026; 25220, Exp. Date: 5/31/2027.",
      "more_code_info": ""
    }
  ]
}