{
  "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": "Ongoing",
      "city": "Parsippany",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA208040"
        ],
        "brand_name": [
          "DABIGATRAN ETEXILATE"
        ],
        "generic_name": [
          "DABIGATRAN ETEXILATE"
        ],
        "manufacturer_name": [
          "Ascend Laboratories, LLC"
        ],
        "product_ndc": [
          "67877-474",
          "67877-475",
          "67877-624"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DABIGATRAN ETEXILATE MESYLATE"
        ],
        "rxcui": [
          "1037045",
          "1037179",
          "1723476"
        ],
        "spl_id": [
          "dd84fc7b-8d68-4a2b-ab48-9458f6586160"
        ],
        "spl_set_id": [
          "3a8ec82a-c367-40dc-9302-e1896fcb05ea"
        ],
        "package_ndc": [
          "67877-475-60",
          "67877-474-60",
          "67877-624-60",
          "67877-624-31"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "SC7NUW5IIT"
        ]
      },
      "product_type": "Drugs",
      "event_id": "91880",
      "recalling_firm": "Ascend Laboratories, LLC",
      "address_1": "339 Jefferson Rd Ste 101",
      "address_2": "N/A",
      "postal_code": "07054-3707",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA.",
      "recall_number": "D-0533-2023",
      "product_description": "Dabigatran Etexilate Capsules, 75 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-474-60.",
      "product_quantity": "13,560 bottles",
      "reason_for_recall": "CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.",
      "recall_initiation_date": "20230314",
      "center_classification_date": "20230413",
      "report_date": "20230405",
      "code_info": "Lot #s:  22142462, 22142463, 22142464, Exp 5/2024; 22143000, 22143001, 22143002, Exp 6/2024."
    }
  ]
}