{
  "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,
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    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Pennington",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA213368"
        ],
        "brand_name": [
          "CHLORPROMAZINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "CHLORPROMAZINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Zydus Pharmaceuticals (USA) Inc."
        ],
        "product_ndc": [
          "70710-1129",
          "70710-1130",
          "70710-1131",
          "70710-1132",
          "70710-1133"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CHLORPROMAZINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "991039",
          "991044",
          "991188",
          "991194",
          "991336"
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        "spl_id": [
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        "package_ndc": [
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          "70710-1129-2",
          "70710-1129-4",
          "70710-1130-1",
          "70710-1130-2",
          "70710-1130-4",
          "70710-1131-1",
          "70710-1131-2",
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          "70710-1133-1",
          "70710-1133-2",
          "70710-1133-4"
        ],
        "is_original_packager": [
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        ],
        "upc": [
          "0370710112912",
          "0370710113216",
          "0370710113018"
        ],
        "unii": [
          "9WP59609J6"
        ]
      },
      "product_type": "Drugs",
      "event_id": "96626",
      "recalling_firm": "Zydus Pharmaceuticals (USA) Inc",
      "address_1": "73 Route 31 N",
      "address_2": "N/A",
      "postal_code": "08534-3601",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within U.S - MS, AL, TN, VT, OH, ND, MN, WI, SC, AR, FL, IN, LA, NJ, AZ, TX, KY and PA",
      "recall_number": "D-0361-2025",
      "product_description": "chlorproMAZINE Hydrochloride Tablets, USP 10 mg, Rx Only, 100 Tablets bottles, Manufactured by: Zydus Lifesciences Ltd., Baddi, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1129-1",
      "product_quantity": "3144 bottles, pack size: 100's Count",
      "reason_for_recall": "CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit",
      "recall_initiation_date": "20250403",
      "center_classification_date": "20250410",
      "report_date": "20250416",
      "code_info": "Lot #: Z400069, Exp.: 12/31/2025"
    }
  ]
}