{
  "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": "Ongoing",
      "city": "Pithampur, District Dhar",
      "state": "",
      "country": "India",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA214596"
        ],
        "brand_name": [
          "PHYTONADIONE"
        ],
        "generic_name": [
          "PHYTONADIONE"
        ],
        "manufacturer_name": [
          "Cipla USA Inc."
        ],
        "product_ndc": [
          "69097-708",
          "69097-709"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS",
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "PHYTONADIONE"
        ],
        "rxcui": [
          "312424",
          "1670192"
        ],
        "spl_id": [
          "b3dd9cac-1295-48b6-b9b1-48d36cb732b9"
        ],
        "spl_set_id": [
          "1add4de5-0f9c-453e-9dd5-abb8077b566a"
        ],
        "package_ndc": [
          "69097-709-96",
          "69097-708-96",
          "69097-708-31"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175965",
          "N0000175982",
          "M0022806",
          "N0000180191",
          "N0000175966"
        ],
        "pharm_class_pe": [
          "Increased Prothrombin Activity [PE]",
          "Reversed Anticoagulation Activity [PE]"
        ],
        "pharm_class_cs": [
          "Vitamin K [CS]"
        ],
        "pharm_class_epc": [
          "Vitamin K [EPC]",
          "Warfarin Reversal Agent [EPC]"
        ],
        "unii": [
          "A034SE7857"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97909",
      "recalling_firm": "Cipla Limited",
      "address_1": "Plot No. 9 & 10, Pharma Zone Phase Ii",
      "address_2": "Section Iiii, Indore Special Economic Zone",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0197-2026",
      "product_description": "Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, Rx Only, Mfd. by: Cipla Ltd. India At M/s Immacule Lifesciences PVT. Ltd. India. Mfd. for: Cipla USA, Inc. Warren, NJ 07059. Vial NDC# 69097-708-31; Carton NDC 69097-708-96",
      "product_quantity": "4,438 10x1mL cartons",
      "reason_for_recall": "Failed Stability Specifications: Observed OOS results: eg results for colour index",
      "recall_initiation_date": "20251031",
      "center_classification_date": "20251128",
      "report_date": "20251210",
      "code_info": "Batch # PH0072404A, PH0082404A, Exp. Date December 31, 2025",
      "more_code_info": ""
    }
  ]
}