{
  "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": "San Juan",
      "state": "PR",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "M012"
        ],
        "brand_name": [
          "PECGEN DMX"
        ],
        "generic_name": [
          "DEXTROMETHORPHAN HBR, GUAIFENESIN"
        ],
        "manufacturer_name": [
          "KRAMER NOVIS"
        ],
        "product_ndc": [
          "52083-630"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DEXTROMETHORPHAN HYDROBROMIDE",
          "GUAIFENESIN"
        ],
        "rxcui": [
          "1441364"
        ],
        "spl_id": [
          "73a7e53a-91e6-4f2a-98f0-d73ba7995194"
        ],
        "spl_set_id": [
          "a627824c-5e3d-4672-a047-6c801b50b432"
        ],
        "package_ndc": [
          "52083-630-16"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0352083630163"
        ],
        "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": "82968",
      "recalling_firm": "Novis PR, Inc.",
      "address_1": "320 Ave Barbosa",
      "address_2": "N/A",
      "postal_code": "00917-4315",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Puerto Rico",
      "recall_number": "D-1395-2019",
      "product_description": "Pecgen DMX Cough Suppressant Expectorant, Contains the same active ingredients as Trispec DMX, Sugar Free, Alcohol Free, Dye Free, Gluten Free, Cherry Raspberry Flavor, 16 Fl. oz. (474 mL), Manufactured in the USA for Kramer Novis, San Juan, PR 00917, www.kramernovis.com, NDC 52083-630-16.",
      "product_quantity": "5766 bottles",
      "reason_for_recall": "Labeling: Incorrect Instructions; The product has been found to provide incorrect dosage information on its label due to a typographical error. The drug facts label incorrectly states children 6 to under 2 years of age, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or directed by physician. The label should state children 6 to under 12, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or as directed by physician. Additionally, the label does not advise consumers to consult a doctor for children under 2 years of age.",
      "recall_initiation_date": "20190528",
      "center_classification_date": "20190619",
      "termination_date": "20210210",
      "report_date": "20190619",
      "code_info": "Lot #s: D80202, D80210 Exp. 02/20; D80818, D80819 Exp. 09/20; D80820 Exp. 09/20"
    }
  ]
}