{
  "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": "Lake Forest",
      "state": "IL",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "ANDA088325"
        ],
        "brand_name": [
          "LIDOCAINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "LIDOCAINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Hospira, Inc."
        ],
        "product_ndc": [
          "0409-4275",
          "0409-4713",
          "0409-4278",
          "0409-4279",
          "0409-4776",
          "0409-4282",
          "0409-4277",
          "0409-4276"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INFILTRATION",
          "PERINEURAL"
        ],
        "substance_name": [
          "LIDOCAINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1010033",
          "1010671",
          "1010900",
          "1737343",
          "1737562",
          "1737566",
          "1737568",
          "1737636",
          "1737757",
          "1737763"
        ],
        "spl_id": [
          "78818553-f818-42a1-81b9-e5a5a5da5a27"
        ],
        "spl_set_id": [
          "3b2dd84e-cee8-4e58-d494-395a65a353a0"
        ],
        "package_ndc": [
          "0409-4713-12",
          "0409-4713-26",
          "0409-4713-02",
          "0409-4713-72",
          "0409-4713-62",
          "0409-4713-75",
          "0409-4713-65",
          "0409-4713-42",
          "0409-4713-25",
          "0409-4713-32",
          "0409-4278-16",
          "0409-4278-01",
          "0409-4279-16",
          "0409-4279-02",
          "0409-4776-10",
          "0409-4776-01",
          "0409-4282-11",
          "0409-4282-25",
          "0409-4282-01",
          "0409-4282-12",
          "0409-4282-02",
          "0409-4277-16",
          "0409-4277-01",
          "0409-4277-17",
          "0409-4277-02",
          "0409-4276-16",
          "0409-4276-01",
          "0409-4276-17",
          "0409-4276-02",
          "0409-4275-16",
          "0409-4275-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "V13007Z41A"
        ]
      },
      "product_type": "Drugs",
      "event_id": "87837",
      "recalling_firm": "PFIZER, INC",
      "address_1": "275 N Field Dr Bldg H3-3N",
      "address_2": "",
      "postal_code": "60045-2579",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA, Puerto Rico, and Guam",
      "recall_number": "D-0627-2021",
      "product_description": "1% Lidocaine HCl Injection, USP, 300 mg/30 mL (10 mg/mL), 30 mL Single-dose vial (NDC 0409-4279-16), packaged in 25 vials per tray (NDC 0409-4279-02), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA.",
      "product_quantity": "139,050 vials",
      "reason_for_recall": "Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP",
      "recall_initiation_date": "20210503",
      "center_classification_date": "20210610",
      "termination_date": "20230404",
      "report_date": "20210609",
      "code_info": "Lot EG8933, Exp. 08/01/2022",
      "more_code_info": ""
    }
  ]
}