{
  "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": "Boca Raton",
      "state": "FL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "M"
        ],
        "brand_name": [
          "BRONCOCHEM"
        ],
        "generic_name": [
          "ACETAMINOPHEN-PHENYLEPHRINE HYDROCHLORIDE-CHLORPHENIRAMINE MALEATE"
        ],
        "manufacturer_name": [
          "LABORATORIO MAGNACHEM INTERNATIONAL SRL"
        ],
        "product_ndc": [
          "65131-097"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ACETAMINOPHEN",
          "CHLORPHENIRAMINE MALEATE"
        ],
        "spl_id": [
          "54539b4d-eb99-4198-8486-bfac15605c04"
        ],
        "spl_set_id": [
          "b7d3f54e-59ef-4b85-a88d-b053058dc1f6"
        ],
        "package_ndc": [
          "65131-097-52",
          "65131-097-53",
          "65131-097-12"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0805418097532"
        ],
        "unii": [
          "362O9ITL9D",
          "V1Q0O9OJ9Z"
        ]
      },
      "product_type": "Drugs",
      "event_id": "94015",
      "recalling_firm": "Global Corporation",
      "address_1": "621 Nw 53rd St Ste 240",
      "address_2": "N/A",
      "postal_code": "33487-8291",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0387-2024",
      "product_description": "Broncochem Cold & Tea (acetaminophen, phenylephrine, HCl, chlorpheniramine maleate), packaged in 13g sachets, 25 sachets per box, Made in the Dominican Republic Exclusively for Global Corporation Inc, Boca Raton, FL 33187 USA, NDC 65131-097-12",
      "product_quantity": "2345 boxes",
      "reason_for_recall": "Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.",
      "recall_initiation_date": "20240216",
      "center_classification_date": "20240314",
      "report_date": "20240320",
      "code_info": "Lot #: 123255, 123256, Exp. Date 11/2024; 123637, Exp. Date 03/2025"
    }
  ]
}