{
  "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": [
          "GUAIFENESIN"
        ],
        "manufacturer_name": [
          "Efficient Laboratories Inc"
        ],
        "product_ndc": [
          "58593-829"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "GUAIFENESIN"
        ],
        "rxcui": [
          "310604",
          "1112205"
        ],
        "spl_id": [
          "26e4f72a-b911-8dc6-e063-6394a90a4326"
        ],
        "spl_set_id": [
          "89ea23a5-0da7-407e-83d9-77a0b562f3af"
        ],
        "package_ndc": [
          "58593-829-06",
          "58593-829-04"
        ],
        "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": [
          "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-0292-2022",
      "product_description": "Rompe Pecho Ex Expectorant,  packaged in a) 4 Fl. Oz. (118 mL) bottles NDC 58593-829-04 and b) 6 Fl. Oz. (178 mL) bottles NDC 58593-829-06, Distributed by Efficient Laboratories, Inc. Miami, FL 33166",
      "product_quantity": "a) 7,800 bottles; b) 16,417 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 #: a) 19H20 Exp. August 2022; 19A418 Exp. January 2022; 19E411 Exp. May 2022; b) 19H20 Exp. August 2022; 19J98 Exp. September 2022; 19A418 Exp. January 2022; 19E411 Exp. May 2022"
    }
  ]
}