{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Buena",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA204494"
        ],
        "brand_name": [
          "LIDOCAINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "LIDOCAINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "McKesson Corporation dba SKY Packaging"
        ],
        "product_ndc": [
          "63739-997"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "LIDOCAINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1010878"
        ],
        "spl_id": [
          "0b1800c4-84d7-4c41-acf3-5f3e8f2e2a8c"
        ],
        "spl_set_id": [
          "903cd7bd-6c3d-4068-bb24-e91b1ca1393d"
        ],
        "package_ndc": [
          "63739-997-64"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "V13007Z41A"
        ]
      },
      "product_type": "Drugs",
      "event_id": "88850",
      "recalling_firm": "Teligent Pharma, Inc.",
      "address_1": "105 Lincoln Avenue",
      "address_2": "",
      "postal_code": "08310",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Press Release",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0279-2022",
      "product_description": "Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Manufactured by: Teligent Pharma Inc., Buena, NJ 06310, Distributed by: McKesson Corporation dba Sky Packaging, 497 Southridge Blvd, Suite 101, Memphis, TN 36141, NDC 63739-997-64.",
      "product_quantity": "7,008 glass bottles",
      "reason_for_recall": "CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the products that had cracked seals in caps that were found to be superpotent.",
      "recall_initiation_date": "20211012",
      "center_classification_date": "20211213",
      "termination_date": "20240618",
      "report_date": "20211222",
      "code_info": "Lot #: 16306, Exp. Date 01/2024.",
      "more_code_info": ""
    }
  ]
}