{
  "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": "2026-07-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA211980"
        ],
        "brand_name": [
          "NOREPINEPHRINE BITARTRATE"
        ],
        "generic_name": [
          "NOREPINEPHRINE BITARTRATE"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
          "47335-615"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "NOREPINEPHRINE BITARTRATE"
        ],
        "rxcui": [
          "242969"
        ],
        "spl_id": [
          "4bb42f07-a41e-42f3-92e7-dab665584f84"
        ],
        "spl_set_id": [
          "4bb42f07-a41e-42f3-92e7-dab665584f84"
        ],
        "package_ndc": [
          "47335-615-44",
          "47335-615-40"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "IFY5PE3ZRW"
        ]
      },
      "product_type": "Drugs",
      "event_id": "91983",
      "recalling_firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
      "address_1": "2 Independence Way",
      "address_2": "N/A",
      "postal_code": "08540-6620",
      "voluntary_mandated": "N/A",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0529-2023",
      "product_description": "Norepinephrine Bitartrate Injection, USP, 4 mg/4 mL* (1 mg/mL), 4 mL Single-dose Fliptop Vial (NDC 47335-615-40); packaged in 10 x 4 mL Single-dose Fliptop Vials per carton (NDC 47335-615-44); Rx only, Manufactured by: Gland Pharma Limited, Hyderabad-502307 India; Distributed by: Sun Phamaceutical Industries, Inc., Cranbury, NJ 08512.",
      "product_quantity": "16,450 vials",
      "reason_for_recall": "Failed Impurities/Degradation Specifications: Above the specification limits yielded for related substance norepinephrine sulfonic acid impurity during routine product monitoring.",
      "recall_initiation_date": "20230329",
      "center_classification_date": "20230410",
      "termination_date": "20231031",
      "report_date": "20230419",
      "code_info": "Lot Number: G1510001, Exp 11/2023; G151002, Exp. 12/2023; and G151003, Exp 02/2024"
    }
  ]
}