{
  "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": "Brookhaven",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
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        ],
        "brand_name": [
          "EXTENDED PHENYTOIN SODIUM"
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        "product_ndc": [
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        "route": [
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        "rxcui": [
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        "spl_id": [
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          "65162-212-10",
          "65162-212-50",
          "65162-212-11"
        ],
        "is_original_packager": [
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        ],
        "upc": [
          "0365162212037",
          "0365162212105"
        ],
        "unii": [
          "4182431BJH"
        ]
      },
      "product_type": "Drugs",
      "event_id": "92368",
      "recalling_firm": "Amneal Pharmaceuticals of New York, LLC",
      "address_1": "50 Horseblock Rd",
      "address_2": "N/A",
      "postal_code": "11719-9509",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "LA, PA and OH.",
      "recall_number": "D-0876-2023",
      "product_description": "Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by: Amneal Pharmaceuticals LLC., Bridgewater, NJ 08807, NDC 65162-212-10.",
      "product_quantity": "9,056 bottles",
      "reason_for_recall": "Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)",
      "recall_initiation_date": "20230530",
      "center_classification_date": "20230615",
      "termination_date": "20250610",
      "report_date": "20230621",
      "code_info": "Lot # HL00721A, Exp. 12/2023"
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}