{
  "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": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA076667"
        ],
        "brand_name": [
          "FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI"
        ],
        "generic_name": [
          "FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI"
        ],
        "manufacturer_name": [
          "Dr. Reddy's Laboratories Inc."
        ],
        "product_ndc": [
          "43598-823"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "FEXOFENADINE HYDROCHLORIDE",
          "PSEUDOEPHEDRINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "997406"
        ],
        "spl_id": [
          "d024126e-de41-3d5e-73d8-bbb2623037e6"
        ],
        "spl_set_id": [
          "6fd05737-d996-b5b6-dccf-bc179a9d606c"
        ],
        "package_ndc": [
          "43598-823-14",
          "43598-823-31",
          "43598-823-35"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "2S068B75ZU",
          "6V9V2RYJ8N"
        ]
      },
      "product_type": "Drugs",
      "event_id": "89042",
      "recalling_firm": "Dr. Reddy's Laboratories, Inc.",
      "address_1": "107 College Rd E",
      "address_2": "N/A",
      "postal_code": "08540-6623",
      "voluntary_mandated": "N/A",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "USA Nationwide.",
      "recall_number": "D-0269-2022",
      "product_description": "Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release Tablets USP Allergy & Congestion, 20 Tablets, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08540, NDC 43598-823-14.",
      "product_quantity": "5016 cartons",
      "reason_for_recall": "Failed dissolution specifications",
      "recall_initiation_date": "20211112",
      "center_classification_date": "20211207",
      "termination_date": "20230623",
      "report_date": "20211215",
      "code_info": "Lot #: AC2103329F, Exp 1/2023",
      "more_code_info": ""
    }
  ]
}