{
  "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": "Completed",
      "city": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA211858"
        ],
        "brand_name": [
          "MESALAMINE"
        ],
        "generic_name": [
          "MESALAMINE"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
          "63304-175"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "MESALAMINE"
        ],
        "rxcui": [
          "686429"
        ],
        "spl_id": [
          "3f29d761-eab5-4f6b-a4f4-ffcc072648e3"
        ],
        "spl_set_id": [
          "fd8b02de-7dfa-444d-a1f8-1436b578e0cb"
        ],
        "package_ndc": [
          "63304-175-13"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175781",
          "M0000971"
        ],
        "pharm_class_epc": [
          "Aminosalicylate [EPC]"
        ],
        "pharm_class_cs": [
          "Aminosalicylic Acids [CS]"
        ],
        "unii": [
          "4Q81I59GXC"
        ]
      },
      "product_type": "Drugs",
      "event_id": "93820",
      "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-0268-2024",
      "product_description": "Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablets per bottle, Once Daily, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191 (U.T. of D & NH), INDIA, NDC 63304-175-13.",
      "product_quantity": "10,690 bottles",
      "reason_for_recall": "CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.",
      "recall_initiation_date": "20240118",
      "center_classification_date": "20240125",
      "report_date": "20240131",
      "code_info": "Lot #s: DNE0875A Exp. 01/31/2025; DNE0876A, DNE0877A, DNE1080A, DNE1081A Exp. 02/28/2025; DNE1147A, DNE1148A Exp. 03/31/2025."
    }
  ]
}