{
  "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": "Panchmahal",
      "state": "N/A",
      "country": "India",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA215076"
        ],
        "brand_name": [
          "DOXEPIN HYDROCHLORIDE"
        ],
        "generic_name": [
          "DOXEPIN HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Alembic Pharmaceuticals Inc."
        ],
        "product_ndc": [
          "62332-637",
          "62332-638",
          "62332-645",
          "62332-639",
          "62332-640"
        ],
        "product_type": [
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        ],
        "route": [
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        ],
        "substance_name": [
          "DOXEPIN HYDROCHLORIDE"
        ],
        "rxcui": [
          "1000048",
          "1000058",
          "1000070",
          "1000076",
          "1000097"
        ],
        "spl_id": [
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        "package_ndc": [
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          "62332-637-91",
          "62332-638-31",
          "62332-638-91",
          "62332-645-31",
          "62332-645-91",
          "62332-639-31",
          "62332-639-91",
          "62332-640-31",
          "62332-640-91",
          "2305015142"
        ],
        "is_original_packager": [
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        "upc": [
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        ],
        "unii": [
          "3U9A0FE9N5"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97323",
      "recalling_firm": "Alembic Pharmaceuticals Limited",
      "address_1": "Formulation Division, Village Panelav, P.O. Tajpura, Near Baska, Taluka Halol",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "N/A",
      "distribution_pattern": "Nationwide in the USA.",
      "recall_number": "D-0566-2025",
      "product_description": "Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panela v 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-637-31",
      "product_quantity": "9,492 bottles",
      "reason_for_recall": "CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.",
      "recall_initiation_date": "20250725",
      "center_classification_date": "20250801",
      "report_date": "20250813",
      "code_info": "Lot: 2305015142, Exp. Date: 9/30/2025",
      "more_code_info": ""
    }
  ]
}