{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "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": "89135",
      "recalling_firm": "Teligent Pharma, Inc.",
      "address_1": "105 Lincoln Avenue",
      "address_2": "",
      "postal_code": "08310",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distributed to a wholesaler in CO who further distributed Nationwide in the USA",
      "recall_number": "D-0296-2022",
      "product_description": "Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured by Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging, 4971 Southridge Blvd., Suite 101, Memphis, TN 38141, NDC 63739-997-64",
      "product_quantity": "7,176 bottles",
      "reason_for_recall": "Superpotent Drug: Minimally superpotent",
      "recall_initiation_date": "20211130",
      "center_classification_date": "20211228",
      "report_date": "20220105",
      "code_info": "Lot #: 15594, Exp Date 05/2023",
      "more_code_info": ""
    }
  ]
}