{
  "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 III",
      "openfda": {
        "application_number": [
          "ANDA207719"
        ],
        "brand_name": [
          "PHYTONADIONE"
        ],
        "generic_name": [
          "PHYTONADIONE"
        ],
        "manufacturer_name": [
          "Dr.Reddy's Laboratories Inc"
        ],
        "product_ndc": [
          "43598-405"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS",
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "PHYTONADIONE"
        ],
        "rxcui": [
          "1670192"
        ],
        "spl_id": [
          "c4a2bf44-0ad2-c0d2-164f-562ba6df930c"
        ],
        "spl_set_id": [
          "02445c07-7b4b-cd70-54e8-ebefc814f547"
        ],
        "package_ndc": [
          "43598-405-11",
          "43598-405-16"
        ],
        "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": "90868",
      "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": "USA nationwide",
      "recall_number": "D-0007-2023",
      "product_description": "Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules per carton, Rx only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, NDC 43598-405-16",
      "product_quantity": "2,838 ampules",
      "reason_for_recall": "Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.",
      "recall_initiation_date": "20220914",
      "center_classification_date": "20221006",
      "report_date": "20221012",
      "code_info": "Lot # ACB101, Exp 03/2023"
    }
  ]
}