{
  "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": "Earth City",
      "state": "MO",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA077397"
        ],
        "brand_name": [
          "SERTRALINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "SERTRALINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Legacy Pharmaceutical Packaging, LLC"
        ],
        "product_ndc": [
          "68645-521",
          "68645-522",
          "68645-523"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SERTRALINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "312938",
          "312940",
          "312941"
        ],
        "spl_id": [
          "4cc29310-2a31-9e2e-e063-6294a90a8e5d"
        ],
        "spl_set_id": [
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        ],
        "package_ndc": [
          "68645-521-54",
          "68645-522-54",
          "68645-523-54"
        ],
        "original_packager_product_ndc": [
          "69097-833",
          "69097-834",
          "69097-835"
        ],
        "upc": [
          "0368645522548",
          "0368645521541",
          "0368645523545"
        ],
        "unii": [
          "UTI8907Y6X"
        ]
      },
      "product_type": "Drugs",
      "event_id": "93605",
      "recalling_firm": "Legacy Pharmaceutical Packaging LLC",
      "address_1": "13333 Lakefront Dr",
      "address_2": "",
      "postal_code": "63045-1514",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "CA and AR",
      "recall_number": "D-0205-2024",
      "product_description": "Sertraline Tablets, USP 100 mg, 30 tablets per bottle, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Cipla USA, Inc., Warren, NJ 07059, Packaged by: Legacy Pharmaceutical Packaging LLC., Earth City, MO 63045, NDC# 68645-523-54",
      "product_quantity": "161,664 bottles",
      "reason_for_recall": "CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.",
      "recall_initiation_date": "20231211",
      "center_classification_date": "20231226",
      "report_date": "20240103",
      "code_info": "Lot #: 222033, exp. date 08/31/2024",
      "more_code_info": ""
    }
  ]
}