{
  "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": "Miami",
      "state": "FL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "M012"
        ],
        "brand_name": [
          "ROMPE PECHO"
        ],
        "generic_name": [
          "DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL"
        ],
        "manufacturer_name": [
          "Efficient Laboratories Inc"
        ],
        "product_ndc": [
          "58593-235"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DEXTROMETHORPHAN HYDROBROMIDE",
          "GUAIFENESIN",
          "PHENYLEPHRINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1044949"
        ],
        "spl_id": [
          "3e6375e6-6668-3453-e063-6394a90add02"
        ],
        "spl_set_id": [
          "96c4dee1-6e66-4442-a7e3-56e874414c17"
        ],
        "package_ndc": [
          "58593-235-06",
          "58593-235-04",
          "58593-235-08",
          "58593-235-29",
          "58593-235-10"
        ],
        "is_original_packager": [
          true
        ],
        "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": "89205",
      "recalling_firm": "Efficient Laboratories, Inc.",
      "address_1": "7715 NW 64th St",
      "address_2": "N/A",
      "postal_code": "33166-2719",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0290-2022",
      "product_description": "Rompe Pecho CF Cold & Flu Advanced Formula, 6 Fl. oz. (178 mL) bottles,  Distributed by: Efficient Laboratories, Inc. Miami, FL 33166, NDC 58593-235-06",
      "product_quantity": "10,833 bottles",
      "reason_for_recall": "Microbial Contamination of Non-Sterile Products",
      "recall_initiation_date": "20210824",
      "center_classification_date": "20211222",
      "termination_date": "20221208",
      "report_date": "20211229",
      "code_info": "Lot #: 19F88 Exp. June 2022; 19G164 Exp. July 2022."
    }
  ]
}