{
  "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": [
          "ANDA216120"
        ],
        "brand_name": [
          "ATROPINE SULFATE"
        ],
        "generic_name": [
          "ATROPINE SULFATE"
        ],
        "manufacturer_name": [
          "American Regent, Inc."
        ],
        "product_ndc": [
          "0517-1001",
          "0517-1004"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "ATROPINE SULFATE"
        ],
        "rxcui": [
          "1190795",
          "1666781"
        ],
        "spl_id": [
          "1c500ed9-94a9-472c-bfb7-50e1fcfc31fb"
        ],
        "spl_set_id": [
          "6fee1727-52b7-4f73-ab45-ef47d6a1c5bb"
        ],
        "package_ndc": [
          "0517-1004-01",
          "0517-1004-25",
          "0517-1001-01",
          "0517-1001-25"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0305171004254",
          "0305171001253"
        ],
        "unii": [
          "03J5ZE7KA5"
        ]
      },
      "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-0795-2026",
      "product_description": "Atropine Sulfate injection, USP, 1 mg/mL, For intravenous Use, Sterile, packaged in a) 1 mL Single-Dose Vial (NDC 0517-1001-01), and b) 25x1 mL Single-Dose Vial (NDC 0517-1001-25), Rx only, AMERICAN REGENT INC., SHIRLEY, NY 11967.",
      "product_quantity": "89,775 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 #: 24353, Exp. Date: 9/30/2026.",
      "more_code_info": ""
    }
  ]
}