{
  "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": "Columbus",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA209755"
        ],
        "brand_name": [
          "CHLORPROMAZINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "CHLORPROMAZINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "American Health Packaging"
        ],
        "product_ndc": [
          "60687-419",
          "60687-430",
          "60687-441",
          "60687-452",
          "60687-463"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CHLORPROMAZINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "991039",
          "991044",
          "991188",
          "991194",
          "991336"
        ],
        "spl_id": [
          "4342f33e-4430-7a74-e063-6294a90adba7"
        ],
        "spl_set_id": [
          "d43718e5-66d7-44f9-9fc8-80d38d3e41ce"
        ],
        "package_ndc": [
          "60687-419-11",
          "60687-419-01",
          "60687-430-11",
          "60687-430-01",
          "60687-430-65",
          "60687-441-11",
          "60687-441-01",
          "60687-452-11",
          "60687-452-01",
          "60687-463-11",
          "60687-463-01"
        ],
        "original_packager_product_ndc": [
          "69238-1054",
          "69238-1056",
          "69238-1058",
          "69238-1060",
          "69238-1062"
        ],
        "unii": [
          "9WP59609J6"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97533",
      "recalling_firm": "Amerisource Health Services LLC",
      "address_1": "2550 John Glenn Ave Ste A",
      "address_2": "N/A",
      "postal_code": "43217-1188",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0647-2025",
      "product_description": "chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, packaged as a) 50 (5x10) blisterpacks, NDC: 60687-430-65; (Individual Dose NDC: 60687-430-11); b) 100 (10x10) blisterpacks, NDC: 60687-430-01, (Individual Dose NDC: 60687-430-11), Rx Only,  Distributed by: American Health Packaging, Columbus, Ohio 43217.",
      "product_quantity": "2,708 cartons",
      "reason_for_recall": "Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.",
      "recall_initiation_date": "20250827",
      "center_classification_date": "20250915",
      "report_date": "20250924",
      "code_info": "Lot:  a)1020919, 1021133, Exp 09/30/2026; 1021447, Exp 10/31/2026; 1021741, 1022202, Exp 11/30/2026; 1022474, Exp 12/31/2026  Lot: b) 1020460, exp 08/31/2026; 1022417, exp 12/31/2026"
    }
  ]
}