{
  "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": "2026-07-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA209735"
        ],
        "brand_name": [
          "ESOMEPRAZOLE MAGNESIUM"
        ],
        "generic_name": [
          "ESOMEPRAZOLE MAGNESIUM"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc"
        ],
        "product_ndc": [
          "63304-734",
          "63304-735"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ESOMEPRAZOLE MAGNESIUM"
        ],
        "rxcui": [
          "606726",
          "606730"
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        "spl_id": [
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        ],
        "spl_set_id": [
          "dc85d0c8-d3c4-4d37-9a5b-8f5f992bb3bf"
        ],
        "package_ndc": [
          "63304-734-90",
          "63304-734-30",
          "63304-734-10",
          "63304-735-90",
          "63304-735-30",
          "63304-735-10"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0363304734300",
          "0363304734904",
          "0363304735307"
        ],
        "unii": [
          "R6DXU4WAY9"
        ]
      },
      "product_type": "Drugs",
      "event_id": "90891",
      "recalling_firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
      "address_1": "2 Independence Way",
      "address_2": "N/A",
      "postal_code": "08540-6620",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0005-2023",
      "product_description": "Esomeprazole Magnesium Delayed-Release Capsules, USP, 40mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-735-90.",
      "product_quantity": "8640 bottles",
      "reason_for_recall": "Superpotent Drug: Out of specification for assay at the 12-month timepoint.",
      "recall_initiation_date": "20220621",
      "center_classification_date": "20221006",
      "termination_date": "20230811",
      "report_date": "20221005",
      "code_info": "Lot AC14304, Exp 12/2022."
    }
  ]
}