{
  "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": "Pulaski",
      "state": "TN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA209755"
        ],
        "brand_name": [
          "CHLORPROMAZINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "CHLORPROMAZINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "AvPAK"
        ],
        "product_ndc": [
          "50268-162",
          "50268-163",
          "50268-164",
          "50268-165",
          "50268-166"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CHLORPROMAZINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "991039",
          "991044",
          "991188",
          "991194",
          "991336"
        ],
        "spl_id": [
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        ],
        "spl_set_id": [
          "9e8cebc0-7fcf-dca8-e053-2a95a90a3369"
        ],
        "package_ndc": [
          "50268-162-11",
          "50268-162-15",
          "50268-163-11",
          "50268-163-15",
          "50268-164-11",
          "50268-164-15",
          "50268-165-11",
          "50268-165-15",
          "50268-166-11",
          "50268-166-12"
        ],
        "original_packager_product_ndc": [
          "69238-1054",
          "69238-1056",
          "69238-1058",
          "69238-1060",
          "69238-1062"
        ],
        "unii": [
          "9WP59609J6"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97548",
      "recalling_firm": "AvKARE",
      "address_1": "615 N 1st St",
      "address_2": "N/A",
      "postal_code": "38478-2403",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "USA Nationwide",
      "recall_number": "D-0644-2025",
      "product_description": "chloroproMAZINE Hydrochloride Tablets, USP, 100 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 38478, NDC 50268-165-15",
      "product_quantity": "2003 cartons",
      "reason_for_recall": "Presence of a foreign substance.",
      "recall_initiation_date": "20250825",
      "center_classification_date": "20250911",
      "report_date": "20250917",
      "code_info": "Lot # 47089, Exp 12/31/25; 47604, Exp 03/31/26"
    }
  ]
}