{
  "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": "Lake Forest",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA078591"
        ],
        "brand_name": [
          "HYDROMORPHONE HYDROCHLORIDE"
        ],
        "generic_name": [
          "HYDROMORPHONE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Teva Parenteral Medicines, Inc.",
          "Hospira, Inc."
        ],
        "product_ndc": [
          "0703-0018",
          "0703-0110",
          "0703-0113",
          "0409-2634"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS",
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "HYDROMORPHONE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1724338",
          "1724340",
          "1724341"
        ],
        "spl_id": [
          "c32108cc-7b73-4921-9f9e-54b3d60c1c6e",
          "f0c8c83c-fb41-4571-a72e-6542311351dd"
        ],
        "spl_set_id": [
          "f0b78db9-a38c-41bb-8233-5e93f7f18c5c",
          "3832ede8-d3fc-455d-ecab-3b77be5869f5"
        ],
        "package_ndc": [
          "0703-0110-01",
          "0703-0110-03",
          "0703-0113-01",
          "0703-0113-03",
          "0703-0018-01",
          "0409-2634-10",
          "0409-2634-01",
          "0409-2634-25",
          "0409-2634-05",
          "0409-2634-50"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0307030110038"
        ],
        "unii": [
          "L960UP2KRW"
        ]
      },
      "product_type": "Drugs",
      "event_id": "69314",
      "recalling_firm": "Hospira Inc.",
      "address_1": "275 N Field Dr",
      "address_2": "",
      "postal_code": "60045-2579",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0044-2015",
      "product_description": "Hydromorphone Hydrochloride Injection, USP, 10 mg/mL, Rx only, packaged in a) 1 mL Single-dose Vial (NDC 0703-0110-01), packaged in 10 x 1 mL Single-dose Vials per carton (NDC 0703-0110-03); Mfd By: Hospira Inc., Lake Forest, IL  60045; Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA  92618; and b) 1 mL Single-dose Vial, packaged in 10 x 1 mL Single-dose Vials per carton (NDC 0409-2634-01), Hospira, Inc., Lake Forest, IL  60045.",
      "product_quantity": "145,600 vials",
      "reason_for_recall": "Lack Of Assurance Of Sterility: Confirmed customer complaints of glass product container vials that may be broken or cracked.",
      "recall_initiation_date": "20141001",
      "center_classification_date": "20141023",
      "termination_date": "20170323",
      "report_date": "20141029",
      "code_info": "Lot #: a) 260753F, 261403F, Exp 1FEB2015; 290153F, Exp 1MAY2015; b) 24-080-DD, Exp 1DEC2014; 25-475-DD, Exp 1JAN2015",
      "more_code_info": ""
    }
  ]
}