{
  "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": "2026-06-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Wilmington",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA208017"
        ],
        "brand_name": [
          "LIDOCAINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "LIDOCAINE HYDROCHLORIDE ANHYDROUS"
        ],
        "manufacturer_name": [
          "Spectra Medical Devices, LLC"
        ],
        "product_ndc": [
          "65282-1605"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "EPIDURAL",
          "INFILTRATION",
          "INTRACAUDAL",
          "PERINEURAL"
        ],
        "substance_name": [
          "LIDOCAINE HYDROCHLORIDE ANHYDROUS"
        ],
        "rxcui": [
          "1737566"
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        "spl_id": [
          "447bfde4-fff3-32a6-e063-6394a90a667e"
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        "spl_set_id": [
          "e8ba012a-08a9-4f67-9f88-3284377e80be"
        ],
        "package_ndc": [
          "65282-1605-1"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0365282160515"
        ],
        "unii": [
          "EC2CNF7XFP"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98976",
      "recalling_firm": "Spectra Medical Devices, Llc",
      "address_1": "299 Ballardvale St",
      "address_2": "Ste 1",
      "postal_code": "01887-1066",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "USA Nationwide",
      "recall_number": "D-0554-2026",
      "product_description": "Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmington, Made in S. Korea, NDC 65282-1605-1.",
      "product_quantity": "210625 ampules",
      "reason_for_recall": "Lack of Assurance of Sterility",
      "recall_initiation_date": "20260512",
      "center_classification_date": "20260602",
      "report_date": "20260610",
      "code_info": "Lot#: AE4013, Exp 1/31/2027; AE5032 & AE5039, Exp 3/31/2028; AE5104, Exp 8/31/2028.",
      "more_code_info": ""
    }
  ]
}