{
  "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,
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    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Parsippany",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA201504"
        ],
        "brand_name": [
          "QUETIAPINE"
        ],
        "generic_name": [
          "QUETIAPINE"
        ],
        "manufacturer_name": [
          "Ascend Laboratories, LLC"
        ],
        "product_ndc": [
          "67877-242",
          "67877-249",
          "67877-250",
          "67877-245",
          "67877-246",
          "67877-247",
          "67877-248"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "QUETIAPINE FUMARATE"
        ],
        "rxcui": [
          "312743",
          "312744",
          "312745",
          "317174",
          "389201",
          "616483",
          "616487"
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        "spl_id": [
          "96978e8e-30c0-4844-a195-a42abd9615b4"
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        "spl_set_id": [
          "3112a006-1c61-47f2-84f5-9a7670d09c9b"
        ],
        "package_ndc": [
          "67877-242-01",
          "67877-242-10",
          "67877-242-38",
          "67877-242-33",
          "67877-249-01",
          "67877-249-10",
          "67877-249-38",
          "67877-249-33",
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          "67877-245-38",
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          "67877-246-33",
          "67877-246-10",
          "67877-247-60",
          "67877-247-38",
          "67877-247-33",
          "67877-247-10",
          "67877-248-01",
          "67877-248-38",
          "67877-248-33",
          "67877-248-10"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "2S3PL1B6UJ"
        ],
        "upc": [
          "367877248011"
        ]
      },
      "product_type": "Drugs",
      "event_id": "81568",
      "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",
      "recall_number": "D-0287-2019",
      "product_description": "Quetiapine Tablets USP 400 mg, 100 tablet bottles, Rx Only,  Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India. Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 --- NDC  67877-248-01, UPC code: 3 67877-248-01 1",
      "product_quantity": "N/A",
      "reason_for_recall": "Presence of Foreign Substance; metal shard found in tablet",
      "recall_initiation_date": "20181114",
      "center_classification_date": "20181128",
      "termination_date": "20200330",
      "report_date": "20181205",
      "code_info": "Lot 7143908, exp Nov 2020"
    }
  ]
}