{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Parsippany",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA207405"
        ],
        "brand_name": [
          "TAMSULOSIN HYDROCHLORIDE"
        ],
        "generic_name": [
          "TAMSULOSIN HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Ascend Laboratories, LLC"
        ],
        "product_ndc": [
          "67877-450"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "TAMSULOSIN HYDROCHLORIDE"
        ],
        "rxcui": [
          "863669"
        ],
        "spl_id": [
          "6803a320-4e6f-4f1a-bfcf-955daf90fa76"
        ],
        "spl_set_id": [
          "ed9988bc-0759-4c36-bee1-11b68dc1c84c"
        ],
        "package_ndc": [
          "67877-450-30",
          "67877-450-60",
          "67877-450-01",
          "67877-450-05",
          "67877-450-10",
          "67877-450-33",
          "67877-450-38"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "11SV1951MR"
        ]
      },
      "product_type": "Drugs",
      "event_id": "82223",
      "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 and Puerto Rico.",
      "recall_number": "D-1066-2019",
      "product_description": "Tamsulosin Hydrochloride Capsules, USP, 0.4 mg, 500-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, INDIA; Distributed by Ascend Laboratories, LLC, Parsippany, NJ  07054, NDC 67877-450-05.",
      "product_quantity": "3,072 bottles",
      "reason_for_recall": "Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed during stability testing.",
      "recall_initiation_date": "20190222",
      "center_classification_date": "20190329",
      "termination_date": "20200318",
      "report_date": "20190313",
      "code_info": "Lot #: 8144652, Exp Jul 2020"
    }
  ]
}