{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Miami Lakes",
      "state": "FL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "M012"
        ],
        "brand_name": [
          "SORBUGEN"
        ],
        "generic_name": [
          "DEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATE"
        ],
        "manufacturer_name": [
          "Kramer Novis"
        ],
        "product_ndc": [
          "52083-660"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DEXTROMETHORPHAN HYDROBROMIDE",
          "GUAIFENESIN"
        ],
        "rxcui": [
          "996520"
        ],
        "spl_id": [
          "796f9d98-f855-437f-9bca-bb322fa5b063"
        ],
        "spl_set_id": [
          "a8f2a2d7-0360-45a8-9635-c852f4a7d7ba"
        ],
        "package_ndc": [
          "52083-660-16"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0352083660160"
        ],
        "nui": [
          "N0000193956",
          "N0000008867",
          "N0000009560"
        ],
        "pharm_class_epc": [
          "Expectorant [EPC]"
        ],
        "pharm_class_pe": [
          "Decreased Respiratory Secretion Viscosity [PE]",
          "Increased Respiratory Secretions [PE]"
        ],
        "unii": [
          "9D2RTI9KYH",
          "495W7451VQ"
        ]
      },
      "product_type": "Drugs",
      "event_id": "83190",
      "recalling_firm": "Pharma-Natural Inc.",
      "address_1": "14500 Nw 60th Ave Bldg 7f",
      "address_2": "N/A",
      "postal_code": "33014",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.",
      "recall_number": "D-1505-2019",
      "product_description": "SORBUGEN NR (Dextromethorphan HBr, 15 mg; Glyceryl Guaiacolate (Guaifenesin), 150 mg) in each 7.5 mL 1 1/2 tsp), GRAPE FLAVOR, 16 Fl.oz. (473 mL) bottle, Manufactured in the USA for Kramer Novis, San Juan, PR  00917, NDC 52083-660-16.",
      "product_quantity": "7392 bottles",
      "reason_for_recall": "CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.",
      "recall_initiation_date": "20190621",
      "center_classification_date": "20190723",
      "termination_date": "20211027",
      "report_date": "20190731",
      "code_info": "All lots remaining within expiry."
    }
  ]
}