{
  "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": "Terminated",
      "city": "New York",
      "state": "NY",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA050441"
        ],
        "brand_name": [
          "CLEOCIN PHOSPHATE"
        ],
        "generic_name": [
          "CLINDAMYCIN PHOSPHATE"
        ],
        "manufacturer_name": [
          "Pharmacia & Upjohn Company LLC"
        ],
        "product_ndc": [
          "0009-0728",
          "0009-0870",
          "0009-0775",
          "0009-0902",
          "0009-3124",
          "0009-3447",
          "0009-3381",
          "0009-3375",
          "0009-3382",
          "0009-6582"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS"
        ],
        "substance_name": [
          "CLINDAMYCIN PHOSPHATE"
        ],
        "rxcui": [
          "205964",
          "309335",
          "309336",
          "309339",
          "685574",
          "685576",
          "685578",
          "706461",
          "1737244",
          "1737245",
          "1737578",
          "1737579",
          "1737581",
          "1737582"
        ],
        "spl_id": [
          "74ff4f17-e32d-43e2-acd2-af9d2b371588"
        ],
        "spl_set_id": [
          "05a75685-0af5-407c-ac57-e380c882b49d"
        ],
        "package_ndc": [
          "0009-0870-21",
          "0009-0870-26",
          "0009-0775-20",
          "0009-0775-26",
          "0009-0902-11",
          "0009-0902-18",
          "0009-0728-05",
          "0009-0728-09",
          "0009-3124-01",
          "0009-3124-03",
          "0009-3447-01",
          "0009-3447-03",
          "0009-3381-01",
          "0009-3381-02",
          "0009-3375-01",
          "0009-3375-02",
          "0009-3382-01",
          "0009-3382-02",
          "0009-6582-02",
          "0009-6582-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "EH6D7113I8"
        ]
      },
      "product_type": "Drugs",
      "event_id": "82386",
      "recalling_firm": "Pfizer Inc.",
      "address_1": "235 E 42nd St",
      "address_2": "N/A",
      "postal_code": "10017-5703",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide USA and Guam",
      "recall_number": "D-1068-2019",
      "product_description": "Cleocin Phosphate, clindamycin injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vial, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Pfizer, Inc, New York, NY 10017, NDC 0009-3124-01",
      "product_quantity": "820 cartons (25 vials per carton)",
      "reason_for_recall": "Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point",
      "recall_initiation_date": "20190315",
      "center_classification_date": "20190329",
      "termination_date": "20220811",
      "report_date": "20190410",
      "code_info": "Lot#: T78191, Exp.04/2019, T97494, Exp.07/2019"
    }
  ]
}