{
  "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": "Completed",
      "city": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA091567"
        ],
        "brand_name": [
          "FEXOFENADINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "FEXOFENADINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "OHM LABORATORIES INC.",
          "CVS PHARMACY, INC"
        ],
        "product_ndc": [
          "51660-998",
          "51316-800"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "FEXOFENADINE HYDROCHLORIDE"
        ],
        "spl_id": [
          "5110b287-1464-50d9-e063-6394a90abe0f",
          "e6bae65e-9f41-4976-bebd-c14e86da14cb"
        ],
        "spl_set_id": [
          "1a1afa95-570d-456e-b436-a0fcfaf68517",
          "7bc13851-291a-4582-8261-13c5022fbdd1"
        ],
        "package_ndc": [
          "51660-998-30",
          "51660-998-55",
          "51316-800-90",
          "51316-800-70",
          "51316-800-45",
          "51316-800-30",
          "51316-800-15",
          "51316-800-08"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "2S068B75ZU"
        ],
        "rxcui": [
          "997420"
        ]
      },
      "product_type": "Drugs",
      "event_id": "93820",
      "recalling_firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
      "address_1": "2 Independence Way",
      "address_2": "N/A",
      "postal_code": "08540-6620",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0273-2024",
      "product_description": "Fexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hour, a) 30 Tablets per bottle, NDC 51660-998-30; Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Made in India, b) 45 Tablets per bottle, NDC 51316-800-45; Distributed by: CVS Pharmacy, Inc., Woonsocket, RI 02895, Made in India, c) 150 Tablets per bottle, NDC 51660-998-55, Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Made in India.",
      "product_quantity": "54,504 bottles",
      "reason_for_recall": "CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.",
      "recall_initiation_date": "20240118",
      "center_classification_date": "20240125",
      "report_date": "20240131",
      "code_info": "Lot #s:  a) DNE0792A Exp. 06/31/2025; DNE1027A Exp. 08/31/2025. b) DNE0793A Exp. 06/31/2025. c) DNE0789A, DNE0790A, DNE0791A Exp. 06/2025, DNE1026A Exp. 08/31/025."
    }
  ]
}