{
  "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": [
          "ANDA090174"
        ],
        "brand_name": [
          "VENLAFAXINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "VENLAFAXINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Zydus Pharmaceuticals USA Inc."
        ],
        "product_ndc": [
          "68382-034",
          "68382-035",
          "68382-036"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "VENLAFAXINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "313581",
          "313583",
          "313585"
        ],
        "spl_id": [
          "8c02c121-fe14-45f5-b2bc-b09fd377531f"
        ],
        "spl_set_id": [
          "5351fe67-17d9-42ec-9e8b-6585fdb9e29e"
        ],
        "package_ndc": [
          "68382-034-06",
          "68382-034-16",
          "68382-034-10",
          "68382-035-06",
          "68382-035-16",
          "68382-035-10",
          "68382-036-06",
          "68382-036-16",
          "68382-036-10"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368382034106",
          "0368382035103",
          "0368382036100"
        ],
        "unii": [
          "7D7RX5A8MO"
        ]
      },
      "product_type": "Drugs",
      "event_id": "74753",
      "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": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-1460-2016",
      "product_description": "Venlafaxine HCL ER Capsule USP, 150mg, packaged in a) 30-count bottles (NDC 68382-036-06), b) 90-count bottles (NDC 68382-036-16), and c) 1000-count bottles, (NDC 68382-036-10), Rx only, Manufactured by :  Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534.",
      "product_quantity": "223,776 bottles",
      "reason_for_recall": "Failed Dissolution Specifications: out of specification dissolution results in retained samples",
      "recall_initiation_date": "20160719",
      "center_classification_date": "20160818",
      "termination_date": "20200921",
      "report_date": "20160824",
      "code_info": "Lot #: a) MR10518, Exp. 9/2017; MR11051, MR11052, MR11053, MR11054, Exp. 10/2017; MR11403, Exp. 11/2017.  Lot #: b)  MR10197, MR10195, Exp. 09/2017; MR11482, Exp.10/2017; MR11479, MR11480, MR11481,  MR11483, MR11665  Exp. 11/2017.  Lot #: c) MR10404, MR10406, MR10521, Exp. 09/2017;  MR10744, MR11055, MR11228, MR11287, MR11285, MR11288, MR11289, MR11286, Exp.10/2017;   MR11567, Exp.11/2017."
    }
  ]
}