{
  "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": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA040327"
        ],
        "brand_name": [
          "ORPHENADRINE CITRATE"
        ],
        "generic_name": [
          "ORPHENADRINE CITRATE"
        ],
        "manufacturer_name": [
          "Sandoz Inc"
        ],
        "product_ndc": [
          "0185-0022"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ORPHENADRINE CITRATE"
        ],
        "rxcui": [
          "994521"
        ],
        "spl_id": [
          "de0e8cdb-788a-4ebe-969d-14d44a14ddc2"
        ],
        "spl_set_id": [
          "239018ff-cec6-46de-ae9d-26c9ec034a32"
        ],
        "package_ndc": [
          "0185-0022-10",
          "0185-0022-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "X0A40N8I4S"
        ]
      },
      "product_type": "Drugs",
      "event_id": "68860",
      "recalling_firm": "Sandoz Inc",
      "address_1": "506 Carnegie Ctr",
      "address_2": "",
      "postal_code": "08540-6243",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-1445-2014",
      "product_description": "Orphenadrine Citrate Extended Release Tablets, 100 mg  a)100-count bottle,  (NDC 0185-0022-01) b) 1000-count bottle, (NDC 0185-0022-10), Rx only, Manufactured by Sandoz Inc., Princeton, NJ 08540.",
      "product_quantity": "781,000 extended release tablets",
      "reason_for_recall": "Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.",
      "recall_initiation_date": "20140711",
      "center_classification_date": "20140723",
      "termination_date": "20170710",
      "report_date": "20140730",
      "code_info": "Lot # DM1316; Exp.  05/16  Lot # DM1318; Exp.  05/16",
      "more_code_info": ""
    }
  ]
}