{
  "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": "2026-07-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "San Juan",
      "state": "PR",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "M012"
        ],
        "brand_name": [
          "G-SUPRESS DX"
        ],
        "generic_name": [
          "DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "KRAMER NOVIS"
        ],
        "product_ndc": [
          "52083-655"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DEXTROMETHORPHAN HYDROBROMIDE",
          "GUAIFENESIN",
          "PHENYLEPHRINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1095503"
        ],
        "spl_id": [
          "48c34e9f-c1dd-4813-8111-ee39233462c1"
        ],
        "spl_set_id": [
          "5dd44337-f3aa-4e73-a206-4a29850a2f7c"
        ],
        "package_ndc": [
          "52083-655-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0352083655012"
        ],
        "nui": [
          "N0000193956",
          "N0000008867",
          "N0000009560"
        ],
        "pharm_class_epc": [
          "Expectorant [EPC]"
        ],
        "pharm_class_pe": [
          "Decreased Respiratory Secretion Viscosity [PE]",
          "Increased Respiratory Secretions [PE]"
        ],
        "unii": [
          "9D2RTI9KYH",
          "495W7451VQ",
          "04JA59TNSJ"
        ]
      },
      "product_type": "Drugs",
      "event_id": "92324",
      "recalling_firm": "Novis PR, LLC dba Kramer Novis",
      "address_1": "320 Ave Barbosa",
      "address_2": "N/A",
      "postal_code": "00917-4315",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Puerto Rico",
      "recall_number": "D-0868-2023",
      "product_description": "G-Supress DX (Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl) Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant, Cherry Flavor Sugar & Alcohol Free, packaged in a bottle Net Content: 30 mL (1 oz.) further packaged in a carton, Manufactured in the USA for Kramer Novis, San Juan, PR 00917, NDC 52083-655-01",
      "product_quantity": "9077 bottles",
      "reason_for_recall": "Product mix-up: incorrect product was found inside the G-Supress DX product carton.",
      "recall_initiation_date": "20230420",
      "center_classification_date": "20230606",
      "termination_date": "20240913",
      "report_date": "20230607",
      "code_info": "Lot: D20911, Exp. Oct/25"
    }
  ]
}