{
  "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": [
          "Walgreens Company"
        ],
        "product_ndc": [
          "0363-1606"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "FEXOFENADINE HYDROCHLORIDE",
          "PSEUDOEPHEDRINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "997406"
        ],
        "spl_id": [
          "22a37aee-5811-616b-a794-4c24bd940d73"
        ],
        "spl_set_id": [
          "37c1ce51-fb5d-7ebf-bbcd-1b2fd41d45b3"
        ],
        "package_ndc": [
          "0363-1606-30",
          "0363-1606-20"
        ],
        "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-0378-2022",
      "product_description": "Wal-Fex D, Fexofenadine HCl 60mg/Antihistamine & Pseudoephedrine HCl 120mg/Nasal Decongestant, Extended Release Tablets USP, a) 20 Extended Release Tablets per box, NDC 0363-1606-20, b) 30 Extended Release Tablets per box, NDC 0363-1606-30, Distributed by: Walgreen Co, 200 Wilmot Rd., Deerfield, IL 60015, Made in India.",
      "product_quantity": "67,848 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:   a) (20-count box): AC2000968D, Exp. 8/31/2022; AC2103330J, Exp. 1/31/2023; AC2106452A; AC2106452H, Exp. 3/31/2023.  b) (30-count box): 79C002624C, Exp. 4/30/2022; AC2103328B; AC2103328C; AC2103330A; AC2103330B, Exp. 1/31/2023."
    }
  ]
}