{
  "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": "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": [
          "The Kroger Co."
        ],
        "product_ndc": [
          "30142-611"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "FEXOFENADINE HYDROCHLORIDE",
          "PSEUDOEPHEDRINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "997406"
        ],
        "spl_id": [
          "29c914f7-dfd8-2f34-2cab-9a239e6c58a9"
        ],
        "spl_set_id": [
          "8cf0b878-ec13-fd44-d56f-f44af7c249ed"
        ],
        "package_ndc": [
          "30142-611-14"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "2S068B75ZU",
          "6V9V2RYJ8N"
        ]
      },
      "product_type": "Drugs",
      "event_id": "89364",
      "recalling_firm": "Dr. Reddy's Laboratories, Inc.",
      "address_1": "107 College Rd E",
      "address_2": "N/A",
      "postal_code": "08540-6623",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0381-2022",
      "product_description": "Kroger, Allergy Relief-D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl 120mg/Nasal Decongestant, Extended-Release Tablets USP, 20 tablets per box, NDC 30142-611-14, Distributed by the Kroger Co., Cincinnati, Ohio, 45202, Made in India.",
      "product_quantity": "11,064 boxes",
      "reason_for_recall": "Failed Dissolution Specifications",
      "recall_initiation_date": "20220104",
      "center_classification_date": "20220118",
      "termination_date": "20231020",
      "report_date": "20220126",
      "code_info": "Lot #s: AC2000968E, Exp. 8/31/2022; AC2103328A; AC2103330I, Exp. 1/31/2023; AC2106452B, Exp. 3/31/2023."
    }
  ]
}