{
  "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": "Terminated",
      "city": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "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": [
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        ],
        "package_ndc": [
          "0185-0022-10",
          "0185-0022-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "X0A40N8I4S"
        ]
      },
      "product_type": "Drugs",
      "event_id": "88937",
      "recalling_firm": "Sandoz, Inc",
      "address_1": "506 Carnegie Ctr Ste 400",
      "address_2": "",
      "postal_code": "08540-6243",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Press Release",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0753-2022",
      "product_description": "Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufactured by Sandoz Inc., Princeton, NJ 08540 NDC 0185-0022-01.",
      "product_quantity": "7908 bottles(790,800 extended release tablets)",
      "reason_for_recall": "CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.",
      "recall_initiation_date": "20220321",
      "center_classification_date": "20220406",
      "termination_date": "20230814",
      "report_date": "20220413",
      "code_info": "Lot #: JX6411, JX6413, Exp. 05/2022   Lot #: KC0723,KC3303, Exp. 08/2022  Lot #: KE4348, KE7169,KE4349, Exp. 11/2022  Lot #: KL3199, KM0072,KS3939, Exp. 03/2023  Lot #: LA7704, LA7703,LA9243, Exp. 11/2023",
      "more_code_info": ""
    }
  ]
}