{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "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"
        ],
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        ],
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          "16714-048",
          "16714-049",
          "16714-050",
          "16714-051"
        ],
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        ],
        "route": [
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        ],
        "substance_name": [
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        ],
        "rxcui": [
          "991039",
          "991044",
          "991188",
          "991194",
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        ],
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        "package_ndc": [
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          "16714-048-01",
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          "16714-050-01",
          "16714-051-01"
        ],
        "is_original_packager": [
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        ],
        "unii": [
          "9WP59609J6"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97534",
      "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": "N/A",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0637-2025",
      "product_description": "Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141.  NDC: 16714-050-01",
      "product_quantity": "N/A",
      "reason_for_recall": "CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit",
      "recall_initiation_date": "20250903",
      "center_classification_date": "20250910",
      "report_date": "20250917",
      "code_info": "Lot #: Z305456, Exp Date 31-10-25; Z401156, Exp Date 28-02-26; Z407306, Exp Date 30-11-26"
    }
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}