{
  "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": "Terminated",
      "city": "IRVING",
      "state": "TX",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA216632"
        ],
        "brand_name": [
          "CABTREO"
        ],
        "generic_name": [
          "CLINDAMYCIN PHOSPHATE/BENZOYL PEROXIDE/ADAPALENE"
        ],
        "manufacturer_name": [
          "Bausch Health US LLC"
        ],
        "product_ndc": [
          "0187-0006"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "CLINDAMYCIN PHOSPHATE",
          "BENZOYL PEROXIDE",
          "ADAPALENE"
        ],
        "rxcui": [
          "2668198",
          "2668204"
        ],
        "spl_id": [
          "338bc721-434d-cbc2-e063-6394a90abc47"
        ],
        "spl_set_id": [
          "9468da0f-9978-4c58-8135-0274c3415084"
        ],
        "package_ndc": [
          "0187-0006-10",
          "0187-0006-25",
          "0187-0006-35"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175607",
          "M0018962"
        ],
        "pharm_class_epc": [
          "Retinoid [EPC]"
        ],
        "pharm_class_cs": [
          "Retinoids [CS]"
        ],
        "unii": [
          "EH6D7113I8",
          "W9WZN9A0GM",
          "1L4806J2QF"
        ]
      },
      "product_type": "Drugs",
      "event_id": "94023",
      "recalling_firm": "MCKESSON CORPORATION",
      "address_1": "6555 NORTH STATE HIGHWA",
      "address_2": "N/A",
      "postal_code": "75039",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Nationwide in the US",
      "recall_number": "D-0347-2024",
      "product_description": "CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1%, Not for Oral, Ophthalmic or Intravaginal Use, Rx Only, Net Wt. 50g, Distributed by Bausch Health US, LLC Bridgewater, NJ 08807 USA, Manufactured by: Bausch Health Companies, Inc. Laval Quebec H7L 448, Canada, NDC 0187-0006-25.",
      "product_quantity": "42 units",
      "reason_for_recall": "CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated.",
      "recall_initiation_date": "20240212",
      "center_classification_date": "20240222",
      "termination_date": "20241001",
      "report_date": "20240228",
      "code_info": "Lot: 7001796, Exp 05/31/2025"
    }
  ]
}