{
  "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": "2026-09-16",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Bridgewater",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA217410"
        ],
        "brand_name": [
          "FLUPHENAZINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "FLUPHENAZINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Ajanta Pharma USA Inc."
        ],
        "product_ndc": [
          "27241-252",
          "27241-255",
          "27241-254",
          "27241-253"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "FLUPHENAZINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "859841",
          "860918",
          "865117",
          "865123"
        ],
        "spl_id": [
          "0069bda4-a743-4edd-a15f-a53cba1a2bff"
        ],
        "spl_set_id": [
          "47695e20-9c0b-4a6b-ab1a-1dfaa75e96d8"
        ],
        "package_ndc": [
          "27241-255-01",
          "27241-254-01",
          "27241-253-01",
          "27241-252-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0327241255014",
          "0327241252013",
          "0327241253010",
          "0327241254017"
        ],
        "unii": [
          "ZOU145W1XL"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99733",
      "recalling_firm": "Ajanta Pharma USA Inc",
      "address_1": "400 Crossing Blvd Ste 102",
      "address_2": "",
      "postal_code": "08807-2863",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the U.S",
      "recall_number": "D-0836-2026",
      "product_description": "Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only,  Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-255-01.",
      "product_quantity": "403,200 tablets",
      "reason_for_recall": "Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.1 percent. Spec: 1.0 percent.",
      "recall_initiation_date": "20260825",
      "center_classification_date": "20260908",
      "report_date": "20260916",
      "code_info": "Lot #: DJ23254, Exp. Date 11/30/2026; DJ10205, Exp. Date 04/30/2027.",
      "more_code_info": ""
    }
  ]
}