{
  "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": "East Brunswick",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA207433"
        ],
        "brand_name": [
          "DESIPRAMINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "DESIPRAMINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc."
        ],
        "product_ndc": [
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          "23155-579",
          "23155-580",
          "23155-581",
          "23155-582",
          "23155-583"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
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        ],
        "substance_name": [
          "DESIPRAMINE HYDROCHLORIDE"
        ],
        "rxcui": [
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          "1099292",
          "1099296",
          "1099300",
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          "1099316"
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        "package_ndc": [
          "23155-578-01",
          "23155-579-01",
          "23155-580-01",
          "23155-581-01",
          "23155-582-01",
          "23155-583-25"
        ],
        "is_original_packager": [
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        "upc": [
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          "0323155582017",
          "0323155578010",
          "0323155583250",
          "0323155581010",
          "0323155580013"
        ],
        "unii": [
          "1Y58DO4MY1"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97770",
      "recalling_firm": "Heritage Pharmaceuticals Inc",
      "address_1": "1 Tower Center Blvd Ste 1700",
      "address_2": "N/A",
      "postal_code": "08816-1145",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S. Nationwide.",
      "recall_number": "D-0110-2026",
      "product_description": "Desipramine Hydrochloride Tablets, USP, 75 mg, 100 count bottle (NDC 23155-581-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.",
      "product_quantity": "2,418 bottles.",
      "reason_for_recall": "CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.",
      "recall_initiation_date": "20251006",
      "center_classification_date": "20251027",
      "report_date": "20251105",
      "code_info": "Lot#: 18036662, Exp. Date: 07/31/2026  Lot#: 18037649, Exp. Date: 03/31/2027"
    }
  ]
}