{
  "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 MAX MULTI SYMPTOMS"
        ],
        "generic_name": [
          "ACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN"
        ],
        "manufacturer_name": [
          "EFFICIENT LABORATORIES INC"
        ],
        "product_ndc": [
          "58593-828"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ACETAMINOPHEN",
          "DEXTROMETHORPHAN HYDROBROMIDE",
          "GUAIFENESIN",
          "PHENYLEPHRINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1593450"
        ],
        "spl_id": [
          "265921fa-a795-0300-e063-6294a90a6793"
        ],
        "spl_set_id": [
          "938e4e47-d2d9-4b0d-bf88-e9f41b501945"
        ],
        "package_ndc": [
          "58593-828-08"
        ],
        "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": [
          "362O9ITL9D",
          "9D2RTI9KYH",
          "495W7451VQ",
          "04JA59TNSJ"
        ],
        "upc": [
          "000856003095"
        ]
      },
      "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-0293-2022",
      "product_description": "Rompe Pecho Max Multi-Symptoms Maximum Strength, 8 Fl. Oz. (237 mL) bottles, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166 UPC 0 00856 00309 5, NDC 58593-828-08",
      "product_quantity": "4,026 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 #: 19G219 Exp. July 2022"
    }
  ]
}