{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Weston",
      "state": "FL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA076109"
        ],
        "brand_name": [
          "KETOROLAC TROMETHAMINE"
        ],
        "generic_name": [
          "KETOROLAC TROMETHAMINE"
        ],
        "manufacturer_name": [
          "Apotex Corp."
        ],
        "product_ndc": [
          "60505-1003"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "KETOROLAC TROMETHAMINE"
        ],
        "rxcui": [
          "860107"
        ],
        "spl_id": [
          "7d61a595-be30-8226-a32b-c02325c581d9"
        ],
        "spl_set_id": [
          "d9a186ba-74a9-b6d4-1109-1e045ba1763e"
        ],
        "package_ndc": [
          "60505-1003-1",
          "60505-1003-2",
          "6050510031",
          "3605051003"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "4EVE5946BQ"
        ],
        "upc": [
          "360505100316"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97561",
      "recalling_firm": "Apotex Corp.",
      "address_1": "2400 N Commerce Pkwy Ste 400",
      "address_2": "N/A",
      "postal_code": "33326-3253",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the US",
      "recall_number": "D-0677-2025",
      "product_description": "Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-1003-1.",
      "product_quantity": "493,468 bottles",
      "reason_for_recall": "Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns",
      "recall_initiation_date": "20250905",
      "center_classification_date": "20250930",
      "report_date": "20251008",
      "code_info": "Batch # VA0444, exp. date 01/2026 Batch # VA4608, exp. date 01/2026 Batch # TZ7016, exp. date 12/2025  UPC on Bottles: (01)0(03)60505100316 UPC on Cartons: 360505100316"
    }
  ]
}