{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Eatontown",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA019101"
        ],
        "brand_name": [
          "FENTANYL CITRATE"
        ],
        "generic_name": [
          "FENTANYL CITRATE"
        ],
        "manufacturer_name": [
          "Hikma Pharmaceuticals USA Inc."
        ],
        "product_ndc": [
          "0641-6027",
          "0641-6024",
          "0641-6025",
          "0641-6028",
          "0641-6026",
          "0641-6029",
          "0641-6030",
          "0641-6247",
          "0641-6248",
          "0641-6249"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS"
        ],
        "substance_name": [
          "FENTANYL CITRATE"
        ],
        "rxcui": [
          "1735003",
          "1735007",
          "1735008",
          "1735013",
          "2168270",
          "2474269",
          "2629337"
        ],
        "spl_id": [
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        ],
        "spl_set_id": [
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        ],
        "package_ndc": [
          "0641-6024-01",
          "0641-6024-10",
          "0641-6027-01",
          "0641-6027-25",
          "0641-6025-01",
          "0641-6025-10",
          "0641-6028-01",
          "0641-6028-10",
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          "0641-6026-01",
          "0641-6026-05",
          "0641-6029-01",
          "0641-6029-25",
          "0641-6030-01",
          "0641-6247-01",
          "0641-6247-25",
          "0641-6248-01",
          "0641-6248-10",
          "0641-6249-01",
          "0641-6249-10"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "MUN5LYG46H"
        ]
      },
      "product_type": "Drugs",
      "event_id": "71378",
      "recalling_firm": "West-Ward Pharmaceutical Corp.",
      "address_1": "465 Industrial Way W",
      "address_2": "",
      "postal_code": "07724-2209",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-1139-2015",
      "product_description": "Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL), Rx Only, For IV or IM Use Preservative Free, 25 X 5 mL Single Dose Vials per Carton, Manufactured by: West-Ward, Eatontown, NJ 07724 USA, NDC 0641-6028-25.",
      "product_quantity": "14,649 Cartons",
      "reason_for_recall": "Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548).",
      "recall_initiation_date": "20150513",
      "center_classification_date": "20150616",
      "termination_date": "20160406",
      "report_date": "20150624",
      "code_info": "Lot #: 043410, Exp 04/2015; 053391, Exp 05/2015; 073340, Exp 07/2015; 083330, 083333, 083335, Exp 08/2015; 093319, 093321, 093323, Exp 09/2015; 103316, 103318, Exp 10/2015",
      "more_code_info": ""
    }
  ]
}