{
  "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"
        ],
        "manufacturer_name": [
          "Efficient Laboratories Inc"
        ],
        "product_ndc": [
          "58593-275"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DEXTROMETHORPHAN HYDROBROMIDE",
          "GUAIFENESIN"
        ],
        "rxcui": [
          "996520"
        ],
        "spl_id": [
          "411e98a6-621c-3e32-e063-6394a90aa647"
        ],
        "spl_set_id": [
          "d108c712-bc36-41d7-9ccd-720496b5599e"
        ],
        "package_ndc": [
          "58593-275-06",
          "58593-275-10",
          "58593-275-04",
          "58593-275-08"
        ],
        "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"
        ]
      },
      "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-0291-2022",
      "product_description": "Rompe Pecho DM, 6 Fl Oz (178 mL) bottles, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166, NDC 58593-275-06",
      "product_quantity": "27,206 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 #: 19F168 Exp. June 2022; 19G145, 19G361,19G449 19G491 Exp. July 2022."
    }
  ]
}