{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Plainsboro",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA200834"
        ],
        "brand_name": [
          "VENLAFAXINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "VENLAFAXINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Aurobindo Pharma Limited"
        ],
        "product_ndc": [
          "65862-527",
          "65862-528",
          "65862-697"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "VENLAFAXINE HYDROCHLORIDE"
        ],
        "rxcui": [
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          "313583",
          "313585"
        ],
        "spl_id": [
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        "spl_set_id": [
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        "package_ndc": [
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          "65862-527-30",
          "65862-527-90",
          "65862-527-01",
          "65862-527-99",
          "65862-527-59",
          "65862-527-10",
          "65862-528-47",
          "65862-528-30",
          "65862-528-90",
          "65862-528-01",
          "65862-528-99",
          "65862-528-35",
          "65862-528-10",
          "65862-697-47",
          "65862-697-30",
          "65862-697-90",
          "65862-697-01",
          "65862-697-05",
          "65862-697-26",
          "65862-697-10"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0365862528476",
          "0365862527479"
        ],
        "unii": [
          "7D7RX5A8MO"
        ]
      },
      "product_type": "Drugs",
      "event_id": "76325",
      "recalling_firm": "Aurobindo Pharma USA Inc",
      "address_1": "666 Plainsboro Rd Ste 210",
      "address_2": "N/A",
      "postal_code": "08536-3004",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the US",
      "recall_number": "D-0474-2017",
      "product_description": "Venlafaxine Hydrochloride extended release capsules, 37.5 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North, Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 072 India, NDC 65862-527-30",
      "product_quantity": "47,040 bottles",
      "reason_for_recall": "Failed Tablet/Capsule Specifications: Some bottles contain  punctured, and/or clumped/melted capsules.",
      "recall_initiation_date": "20161222",
      "center_classification_date": "20170213",
      "termination_date": "20190319",
      "report_date": "20170222",
      "code_info": "Lot #: VI3716010-A, Exp. 04/2018",
      "more_code_info": ""
    }
  ]
}