{
  "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": "2026-09-09",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Deerfield",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA208532"
        ],
        "brand_name": [
          "DEXMEDETOMIDINE HYDROCHLORIDE"
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        "generic_name": [
          "DEXMEDETOMIDINE HYDROCHLORIDE"
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        ],
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          "0338-9555",
          "0338-9557"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
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        "route": [
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        "substance_name": [
          "DEXMEDETOMIDINE HYDROCHLORIDE"
        ],
        "rxcui": [
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          "0338-9557-12"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "1018WH7F9I"
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      },
      "product_type": "Drugs",
      "event_id": "99500",
      "recalling_firm": "Baxter Healthcare Corporation",
      "address_1": "1 Baxter Pkwy",
      "address_2": "N/A",
      "postal_code": "60015-4625",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide; Puerto Rico; and Chile.",
      "recall_number": "D-0810-2026",
      "product_description": "Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, 400 mcg per 100 mL (4 mcg/mL) in Galaxy 100 mL Single Dose Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-9557-12.",
      "product_quantity": "N/A",
      "reason_for_recall": "CGMP Deviations",
      "recall_initiation_date": "20260806",
      "center_classification_date": "20260828",
      "report_date": "20260909",
      "code_info": "Lot # NC188654, Exp Date: 08/31/2027; Lot # NC188821, Exp Date: 09/30/2027; Lot # NC193658, NC193702, Exp Date: 01/31/2028.",
      "more_code_info": ""
    }
  ]
}