{
  "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": "Mahwah",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA204637"
        ],
        "brand_name": [
          "AZELAIC ACID"
        ],
        "generic_name": [
          "AZELAIC ACID"
        ],
        "manufacturer_name": [
          "Glenmark Pharmaceuticals Inc., USA"
        ],
        "product_ndc": [
          "68462-626"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "AZELAIC ACID"
        ],
        "rxcui": [
          "1041518"
        ],
        "spl_id": [
          "28cca0c1-2f38-4fa2-8aaf-d3c8978b0fc6"
        ],
        "spl_set_id": [
          "0b5ab22e-c78a-4429-9a76-a4ba2d11fcde"
        ],
        "package_ndc": [
          "68462-626-52"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368462626528"
        ],
        "nui": [
          "N0000008841",
          "N0000009982"
        ],
        "pharm_class_pe": [
          "Decreased Protein Synthesis [PE]",
          "Decreased Sebaceous Gland Activity [PE]"
        ],
        "unii": [
          "F2VW3D43YT"
        ]
      },
      "product_type": "Drugs",
      "event_id": "95022",
      "recalling_firm": "Glenmark Pharmaceuticals Inc., USA",
      "address_1": "750 Corporate Dr",
      "address_2": "N/A",
      "postal_code": "07430-2009",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S. Nationwide",
      "recall_number": "D-0621-2024",
      "product_description": "Glenmark, Azelaic Acid Gel, 15 %, 50 grams, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa, 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-626-52.",
      "product_quantity": "14,004 cartons",
      "reason_for_recall": "CGMP Deviations",
      "recall_initiation_date": "20240722",
      "center_classification_date": "20240729",
      "report_date": "20240807",
      "code_info": "Lot# 19241453; Exp MARCH 2026"
    }
  ]
}