{
  "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": [
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        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CHLORPROMAZINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "991039",
          "991044",
          "991188",
          "991194",
          "991336"
        ],
        "spl_id": [
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        "spl_set_id": [
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        ],
        "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": [
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        "upc": [
          "0368462862018",
          "0368462864012",
          "0368462863015",
          "0368462861011"
        ],
        "unii": [
          "9WP59609J6"
        ]
      },
      "product_type": "Drugs",
      "event_id": "95936",
      "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": "USA Nationwide",
      "recall_number": "D-0160-2025",
      "product_description": "chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-862-01",
      "product_quantity": "",
      "reason_for_recall": "CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.",
      "recall_initiation_date": "20241211",
      "center_classification_date": "20241223",
      "report_date": "20250101",
      "code_info": "Lot#: 17230133, Exp 12/31/2024",
      "more_code_info": ""
    }
  ]
}