{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "New York",
      "state": "NY",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA050733"
        ],
        "brand_name": [
          "ZITHROMAX"
        ],
        "generic_name": [
          "AZITHROMYCIN DIHYDRATE"
        ],
        "manufacturer_name": [
          "Pfizer Laboratories Div Pfizer Inc"
        ],
        "product_ndc": [
          "0069-3150"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "AZITHROMYCIN DIHYDRATE"
        ],
        "rxcui": [
          "1668238",
          "1668240"
        ],
        "spl_id": [
          "b0eb7eb4-90fe-4add-a327-e8be68165a3b"
        ],
        "spl_set_id": [
          "3b631aa1-2d46-40bc-a614-d698301ea4f9"
        ],
        "package_ndc": [
          "0069-3150-84",
          "0069-3150-83"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "5FD1131I7S"
        ]
      },
      "product_type": "Drugs",
      "event_id": "67137",
      "recalling_firm": "Pfizer Inc.",
      "address_1": "235 East 42nd Street",
      "address_2": "",
      "postal_code": "10017-5703",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide and Puerto Rico",
      "recall_number": "D-745-2014",
      "product_description": "Zithromax (azithromycin for injection), 500 mg/vial, Sterile, Rx Only, For I.V. infusion only, No latex, No preservative, Made in Ireland, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017, NDC 0069-3150-84",
      "product_quantity": "101,681 Vials",
      "reason_for_recall": "Failed Impurities/Degradation Specifications: Pfizer is recalling certain lots due to out of specification results for azithromycin N-oxide degradant.",
      "recall_initiation_date": "20140102",
      "center_classification_date": "20140116",
      "termination_date": "20160314",
      "report_date": "20140122",
      "code_info": "Lot Number/Expiration Date  G81845, Exp 10/03/14  0B0CJ, Exp 02/06/15  G44710, Exp 07/10/15  G65241, Exp 07/11/15  G80003, Exp 10/17/15  G82722, Exp 11/27/15  G93028, G95309, Exp: 01/23/16  G97641, Exp 01/30/16",
      "more_code_info": ""
    }
  ]
}