{
  "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": "Pennington",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA077653"
        ],
        "brand_name": [
          "VENLAFAXINE"
        ],
        "generic_name": [
          "VENLAFAXINE"
        ],
        "manufacturer_name": [
          "Zydus Pharmaceuticals USA Inc."
        ],
        "product_ndc": [
          "68382-018",
          "68382-019",
          "68382-020",
          "68382-021",
          "68382-101"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "VENLAFAXINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "313580",
          "313582",
          "313584",
          "313586",
          "314277"
        ],
        "spl_id": [
          "ea404f6c-7e07-4779-a52c-8cffb92718ef"
        ],
        "spl_set_id": [
          "72efad5f-0909-46a5-aa13-ac24fe015fe6"
        ],
        "package_ndc": [
          "68382-018-06",
          "68382-018-14",
          "68382-018-16",
          "68382-018-01",
          "68382-018-05",
          "68382-018-10",
          "68382-019-06",
          "68382-019-14",
          "68382-019-16",
          "68382-019-01",
          "68382-019-05",
          "68382-019-10",
          "68382-020-06",
          "68382-020-14",
          "68382-020-16",
          "68382-020-01",
          "68382-020-05",
          "68382-020-10",
          "68382-021-06",
          "68382-021-14",
          "68382-021-16",
          "68382-021-01",
          "68382-021-05",
          "68382-021-10",
          "68382-101-06",
          "68382-101-14",
          "68382-101-16",
          "68382-101-01",
          "68382-101-05",
          "68382-101-10"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368382019011",
          "0368382018014",
          "0368382021014",
          "0368382101013"
        ],
        "unii": [
          "7D7RX5A8MO"
        ]
      },
      "product_type": "Drugs",
      "event_id": "64604",
      "recalling_firm": "Zydus Pharmaceuticals USA Inc",
      "address_1": "73 Route 31 N",
      "address_2": "",
      "postal_code": "08534-3601",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide.",
      "recall_number": "D-202-2013",
      "product_description": "Venlafaxine Hydrochloride Tablets, 75 mg*, 100-count tablets per bottle, Rx only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India; Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-021-01.",
      "product_quantity": "13,320 bottles",
      "reason_for_recall": "Failed Tablet/Capsule Specifications: Pharmacist complaint of an excessive amount of broken and/or chipped tablets in the bottle.",
      "recall_initiation_date": "20130305",
      "center_classification_date": "20130325",
      "termination_date": "20150504",
      "report_date": "20130403",
      "code_info": "Lot #: MM8490, Exp 09/14",
      "more_code_info": ""
    }
  ]
}