{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Parsippany",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA203817"
        ],
        "brand_name": [
          "MESALAMINE"
        ],
        "generic_name": [
          "MESALAMINE"
        ],
        "manufacturer_name": [
          "Actavis Pharma, Inc."
        ],
        "product_ndc": [
          "0591-2245"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "MESALAMINE"
        ],
        "rxcui": [
          "686429"
        ],
        "spl_id": [
          "1300887a-c110-46b3-a8be-cfceabf0cbf2"
        ],
        "spl_set_id": [
          "ba1e3bd4-fbe0-46a5-961e-167ccb09672c"
        ],
        "package_ndc": [
          "0591-2245-22"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0305912245229"
        ],
        "nui": [
          "N0000175781",
          "M0000971"
        ],
        "pharm_class_epc": [
          "Aminosalicylate [EPC]"
        ],
        "pharm_class_cs": [
          "Aminosalicylic Acids [CS]"
        ],
        "unii": [
          "4Q81I59GXC"
        ]
      },
      "product_type": "Drugs",
      "event_id": "86667",
      "recalling_firm": "Teva Pharmaceuticals USA",
      "address_1": "400 Interpace Pkwy",
      "address_2": "",
      "postal_code": "07054-1120",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the U.S. and PR",
      "recall_number": "D-0069-2021",
      "product_description": "Mesalamine Delayed-Release Tablets, USP 1.2 gram, 120 tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories, FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma Inc., Parsippany, NJ 07054, NDC 0591-2245-22.",
      "product_quantity": "133,829 bottles",
      "reason_for_recall": "Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing.",
      "recall_initiation_date": "20201028",
      "center_classification_date": "20201106",
      "termination_date": "20210826",
      "report_date": "20201118",
      "code_info": "Lot #s: 1342498A, Exp. 12/2020; 1342499A, Exp. 01/2021; 1354638A, Exp. 03/2021; 1354639A, 1358274A, 1358448A, 1364618A, 1369884A, Exp. 05/2021; 1366195A, 1369885A, 1373570A, Exp. 06/2021; 1373571A, Exp. 07/2021; 1388571A, Exp. 01/2022; 1395725A, 1396585A, 1397550A, 1399389A, Exp. 04/2022; 1403885A, 1403886A, Exp. 06/2022.",
      "more_code_info": ""
    }
  ]
}