{
  "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": "Mahwah",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA212144"
        ],
        "brand_name": [
          "CHLORPROMAZINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "CHLORPROMAZINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Glenmark Pharmaceuticals Inc., USA"
        ],
        "product_ndc": [
          "68462-861",
          "68462-862",
          "68462-863",
          "68462-864",
          "68462-865"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CHLORPROMAZINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "991039",
          "991044",
          "991188",
          "991194",
          "991336"
        ],
        "spl_id": [
          "440a4208-83cc-4ffa-952c-d9c0745c342a"
        ],
        "spl_set_id": [
          "a6065ac5-a111-449b-b51b-8bc2907d1ddb"
        ],
        "package_ndc": [
          "68462-861-01",
          "68462-861-10",
          "68462-862-01",
          "68462-862-10",
          "68462-863-01",
          "68462-863-10",
          "68462-864-01",
          "68462-864-10",
          "68462-865-01",
          "68462-865-10"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368462862018",
          "0368462864012",
          "0368462863015",
          "0368462861011"
        ],
        "unii": [
          "9WP59609J6"
        ]
      },
      "product_type": "Drugs",
      "event_id": "95658",
      "recalling_firm": "Glenmark Pharmaceuticals Inc., USA",
      "address_1": "750 Corporate Dr",
      "address_2": "",
      "postal_code": "07430-2009",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA and PR",
      "recall_number": "D-0309-2025",
      "product_description": "chlorproMAZINE Hydrochloride Tablets, USP 100 mg, Rx Only, 100 Tablets per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-864-01",
      "product_quantity": "8160 bottles",
      "reason_for_recall": "CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.",
      "recall_initiation_date": "20250311",
      "center_classification_date": "20250402",
      "report_date": "20250409",
      "code_info": "Lot#s: 17232222 and 17232237, Exp 10/31/2025",
      "more_code_info": ""
    }
  ]
}