{
  "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": "Ongoing",
      "city": "Panchmahal",
      "state": "N/A",
      "country": "India",
      "classification": "Class II",
      "openfda": {
        "application_number": [
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        ],
        "brand_name": [
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        ],
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        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
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        "substance_name": [
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        ],
        "rxcui": [
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        "spl_id": [
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        "spl_set_id": [
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        "package_ndc": [
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        ],
        "is_original_packager": [
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        ],
        "unii": [
          "8ECV571Y37"
        ]
      },
      "product_type": "Drugs",
      "event_id": "96836",
      "recalling_firm": "Alembic Pharmaceuticals Limited",
      "address_1": "Formulation Division, Village Panelav, P.O. Tajpura, Near Baska, Taluka Halol",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide",
      "recall_number": "D-0447-2025",
      "product_description": "Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, Manufactured by Alembic Pharmaceuticals Limitied, Gujarat, India, Made in India, NDC 62332-508-17",
      "product_quantity": "N/A",
      "reason_for_recall": "Failed Impurities/Degradation Specifications",
      "recall_initiation_date": "20250507",
      "center_classification_date": "20250527",
      "report_date": "20250604",
      "code_info": "Lot 7230309, Exp Date: 5/31/2025; Lot 7230310, Exp Date: 5/31/2025; Lot 7230311, Exp Date: 5/31/2025"
    }
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}