{
  "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,
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    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Cherry Hill",
      "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": [
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          "1735007",
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          "2168270",
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        "spl_set_id": [
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        "package_ndc": [
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          "0641-6027-01",
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          "0641-6025-01",
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          "0641-6029-25",
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          "0641-6247-25",
          "0641-6248-01",
          "0641-6248-10",
          "0641-6249-01",
          "0641-6249-10"
        ],
        "is_original_packager": [
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        ],
        "unii": [
          "MUN5LYG46H"
        ]
      },
      "product_type": "Drugs",
      "event_id": "70548",
      "recalling_firm": "West-Ward Pharmaceutical Corporation",
      "address_1": "2 Esterbrook Ln",
      "address_2": "",
      "postal_code": "08003-4002",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0420-2015",
      "product_description": "Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL) 25 x 5 mL Single Dose Vials, For Intravenous or Intramuscular Use, Preservative Free, Rx Only, Manufactured by: West-Ward Pharmaceuticals, Eatontown, NJ 07724, NDC 0641-6028-25.",
      "product_quantity": "445,475 Vials",
      "reason_for_recall": "Failed Impurities/Degradation Specifications; 12 month stability testing.",
      "recall_initiation_date": "20150216",
      "center_classification_date": "20150320",
      "termination_date": "20160726",
      "report_date": "20150401",
      "code_info": "Lot #: 113312, Exp 11/2015; 014315 Exp 01/2016",
      "more_code_info": ""
    }
  ]
}