{
  "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": "Ongoing",
      "city": "Parsippany",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA207105"
        ],
        "brand_name": [
          "ARIPIPRAZOLE"
        ],
        "generic_name": [
          "ARIPIPRAZOLE"
        ],
        "manufacturer_name": [
          "Ascend Laboratories, LLC"
        ],
        "product_ndc": [
          "67877-430",
          "67877-431",
          "67877-432",
          "67877-433",
          "67877-434",
          "67877-435"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ARIPIPRAZOLE"
        ],
        "rxcui": [
          "349490",
          "349545",
          "349547",
          "349553",
          "402131",
          "602964"
        ],
        "spl_id": [
          "583fc581-09d7-4d4f-a079-08ba9d00f775"
        ],
        "spl_set_id": [
          "c7040fef-96a7-4429-9a8e-ec3ab17a8019"
        ],
        "package_ndc": [
          "67877-431-03",
          "67877-431-01",
          "67877-431-05",
          "67877-431-33",
          "67877-431-38",
          "67877-431-32",
          "67877-432-03",
          "67877-432-01",
          "67877-432-05",
          "67877-432-33",
          "67877-432-38",
          "67877-432-32",
          "67877-433-03",
          "67877-433-01",
          "67877-433-05",
          "67877-433-33",
          "67877-433-38",
          "67877-433-32",
          "67877-434-03",
          "67877-434-01",
          "67877-434-05",
          "67877-434-33",
          "67877-434-38",
          "67877-435-03",
          "67877-435-01",
          "67877-435-05",
          "67877-435-33",
          "67877-435-38",
          "67877-430-03",
          "67877-430-01",
          "67877-430-05",
          "67877-430-33",
          "67877-430-38",
          "67877-430-32"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175430"
        ],
        "pharm_class_epc": [
          "Atypical Antipsychotic [EPC]"
        ],
        "unii": [
          "82VFR53I78"
        ]
      },
      "product_type": "Drugs",
      "event_id": "91918",
      "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-0539-2023",
      "product_description": "Aripiprazole Tablets, USP, 20 mg, Rx Only, Packaged in 500-count bottle Manufactured by:  Alkem Laboratories Ltd., INDIA  Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC#: 67877-434-05",
      "product_quantity": "135 bottles",
      "reason_for_recall": "Out of specification (OOS) for Spectroscopic Identification test by IR.",
      "recall_initiation_date": "20230317",
      "center_classification_date": "20230419",
      "report_date": "20230426",
      "code_info": "Lot #22143120, Exp. Date: June 2024"
    }
  ]
}