{
  "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": [
          "GENCONTUSS"
        ],
        "generic_name": [
          "CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "KRAMER NOVIS"
        ],
        "product_ndc": [
          "52083-650"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CHLORPHENIRAMINE MALEATE",
          "DEXTROMETHORPHAN HYDROBROMIDE",
          "PHENYLEPHRINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1363752"
        ],
        "spl_id": [
          "8a52f9ca-43f9-4f88-ae67-2ee6e1541d51"
        ],
        "spl_set_id": [
          "69d16d25-b09b-430e-8e01-0962d840dc21"
        ],
        "package_ndc": [
          "52083-650-16"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0352083650161"
        ],
        "unii": [
          "V1Q0O9OJ9Z",
          "9D2RTI9KYH",
          "04JA59TNSJ"
        ]
      },
      "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-1497-2019",
      "product_description": "GENCONTUSS (Chlorpheniramine Maleate, 2mg; Dextromethorphan HBr, 10 mg; Phenylephrine HCl, 5 mg) in each 5 mL tsp, Cherry Flavor, 16 fl oz (474 mL) bottle, Manufactured in the USA for Kramer Novis, San Juan, PR 00917, NDC 52083-650-16.",
      "product_quantity": "3000 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."
    }
  ]
}