{
  "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": "Memphis",
      "state": "TN",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "brand_name": [
          "DONNATAL"
        ],
        "generic_name": [
          "PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE"
        ],
        "manufacturer_name": [
          "Advanz Pharma (US) Corp."
        ],
        "product_ndc": [
          "59212-425"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ATROPINE SULFATE",
          "HYOSCYAMINE SULFATE",
          "PHENOBARBITAL",
          "SCOPOLAMINE HYDROBROMIDE"
        ],
        "rxcui": [
          "1046815",
          "1046978"
        ],
        "spl_id": [
          "0395fab5-b3e6-4822-872c-16002ae8ff58"
        ],
        "spl_set_id": [
          "c93cccdc-2f92-4cb3-9d14-06acdd51d94c"
        ],
        "package_ndc": [
          "59212-425-10",
          "59212-425-11",
          "59212-425-04"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0359212425102"
        ],
        "unii": [
          "03J5ZE7KA5",
          "F2R8V82B84",
          "YQE403BP4D",
          "451IFR0GXB"
        ]
      },
      "product_type": "Drugs",
      "event_id": "72457",
      "recalling_firm": "Rx PAK",
      "address_1": "4971 Southridge Blvd Ste 111-115",
      "address_2": "N/A",
      "postal_code": "38141-8300",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0053-2016",
      "product_description": "Donnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) tablets, 100-count bottle, Rx only, Manufactured for Concordia Pharmaceuticals, Inc., St. Michael, Barbados BB11005, Manufactured by IriSys, LLC San Diego, CA 92121, Repackaged by: RxPak, Div. of McKesson, Memphis, TN 38141, NDC 59212-425-10",
      "product_quantity": "2530 bottles",
      "reason_for_recall": "Labeling: Not elsewhere classified - Product label incorrectly lists Scopolamine Hydrocodone as an active ingredient on the side panel instead of Scopolamine Hydrobromide.",
      "recall_initiation_date": "20151013",
      "center_classification_date": "20151021",
      "termination_date": "20160630",
      "report_date": "20151028",
      "code_info": "Lot #: 107934 Exp 9/16, 108060 Exp 5/16"
    }
  ]
}