{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Lincoln",
      "state": "RI",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "M013"
        ],
        "brand_name": [
          "MAXIMUM STRENGTH COUGH AND CHEST CONGESTION AND NIGHTTIME SEVERE COLD AND FLU COMBO PACK"
        ],
        "generic_name": [
          "DEXTROMETHORPHAN HBR, GUAIFENESIN, ACETAMINOPHEN, DOXYLAMINE SUCCINATE"
        ],
        "manufacturer_name": [
          "Genexa Inc."
        ],
        "product_ndc": [
          "69676-0079"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "rxcui": [
          "2692302",
          "2692303",
          "2692304"
        ],
        "spl_id": [
          "38f8afad-542e-ae0c-e063-6294a90a243f"
        ],
        "spl_set_id": [
          "18835205-a9e3-15c2-e063-6394a90a8107"
        ],
        "package_ndc": [
          "69676-0079-3",
          "69676-0077-9",
          "69676-0094-9",
          "8500157361"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "850015736155"
        ]
      },
      "product_type": "Drugs",
      "event_id": "95430",
      "recalling_firm": "Denison Pharmaceuticals, LLC",
      "address_1": "1 Powder Hill Rd",
      "address_2": "N/A",
      "postal_code": "02865-4407",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Product was distributed to two accounts that may have distributed the product further to the Retail Level.",
      "recall_number": "D-0033-2025",
      "product_description": "Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP  400mg),  packaged in 4 oz bottles further package in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code # 850015736155",
      "product_quantity": "72,648 bottles",
      "reason_for_recall": "Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.",
      "recall_initiation_date": "20240925",
      "center_classification_date": "20241101",
      "report_date": "20241113",
      "code_info": "Lot# 0104V, Exp 07/2025; 0106V, Exp 09/2024",
      "more_code_info": ""
    }
  ]
}