{
  "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,
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    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Somerset",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA217791"
        ],
        "brand_name": [
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        ],
        "generic_name": [
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        ],
        "product_ndc": [
          "70069-716"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "OPHTHALMIC"
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        "substance_name": [
          "ATROPINE SULFATE"
        ],
        "rxcui": [
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        "spl_id": [
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        ],
        "spl_set_id": [
          "bfdb85b2-86d0-4f32-a8fa-272af48a191c"
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        "package_ndc": [
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        "is_original_packager": [
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        "upc": [
          "0370069716014"
        ],
        "unii": [
          "03J5ZE7KA5"
        ]
      },
      "product_type": "Drugs",
      "event_id": "95997",
      "recalling_firm": "SOMERSET THERAPEUTICS LLC",
      "address_1": "300 Franklin Square Dr",
      "address_2": "",
      "postal_code": "08873-4187",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0169-2025",
      "product_description": "Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873, NDC 70069-716-01",
      "product_quantity": "5,870 bottles",
      "reason_for_recall": "Failed Impurities/Degradation Specifications",
      "recall_initiation_date": "20241216",
      "center_classification_date": "20241231",
      "termination_date": "20250610",
      "report_date": "20250108",
      "code_info": "Lot #: A240211, Exp. Date April 2026",
      "more_code_info": ""
    }
  ]
}