{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Grand Island",
      "state": "NY",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "ANDA088912"
        ],
        "brand_name": [
          "SODIUM CHLORIDE"
        ],
        "generic_name": [
          "SODIUM CHLORIDE"
        ],
        "manufacturer_name": [
          "Fresenius Kabi USA, LLC"
        ],
        "product_ndc": [
          "63323-186"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "SODIUM CHLORIDE"
        ],
        "rxcui": [
          "1807632",
          "1807636",
          "1807637",
          "1807638"
        ],
        "spl_id": [
          "75c567e3-582b-4fff-9a72-f326f1d13c8f"
        ],
        "spl_set_id": [
          "f62481fd-fcdb-4be6-ac13-29c590e925c3"
        ],
        "package_ndc": [
          "63323-186-04",
          "63323-186-02",
          "63323-186-01",
          "63323-186-10",
          "63323-186-03",
          "63323-186-20"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0363323186036"
        ],
        "unii": [
          "451W47IQ8X"
        ]
      },
      "product_type": "Drugs",
      "event_id": "81570",
      "recalling_firm": "Fresenius Kabi USA, LLC",
      "address_1": "3159 Staley Rd",
      "address_2": "N/A",
      "postal_code": "14072-2028",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distributed Nationwide in the USA and Puerto RIco",
      "recall_number": "D-0299-2019",
      "product_description": "SODIUM CHLORIDE INJECTION, USP, 0.9%, 20 mL Single Dose Vial, packaged in a 25-unit tray, Rx Only, APP Pharmaceuticals, LLC Schaumburg, IL 60173. NDC 63323-186-20,  Product code 918620",
      "product_quantity": "1,312,350 20 mL vials",
      "reason_for_recall": "Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect statement on the product insert for product codes 918610 and 918620 indicating that the stoppers do not contain natural rubber latex.  The tray label for these two product codes and the vial label for product code 918620 also incorrectly state that the stoppers do not contain latex.  The above listed product codes and batches being recalled have stoppers containing natural rubber latex.",
      "recall_initiation_date": "20181115",
      "center_classification_date": "20181214",
      "termination_date": "20230501",
      "report_date": "20181212",
      "code_info": "Lot#          EXP date:   6013062 11/2018  6014162 05/2019  6014163 05/2019  6014164 05/2019  6014377 06/2019  6014378 06/2019  6014379 06/2019  6016005 02/2020  6016071 02/2020  6016072 02/2020  6016073 02/2020  6017383 07/2020  6017384 07/2020  6017422 07/2020  6017423 07/2020  6017424 07/2020"
    }
  ]
}