{
  "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 I",
      "openfda": {
        "application_number": [
          "ANDA078591"
        ],
        "brand_name": [
          "HYDROMORPHONE HYDROCHLORIDE"
        ],
        "generic_name": [
          "HYDROMORPHONE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Teva Parenteral Medicines, Inc."
        ],
        "product_ndc": [
          "0703-0018",
          "0703-0110",
          "0703-0113"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS",
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "HYDROMORPHONE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1724338",
          "1724340",
          "1724341"
        ],
        "spl_id": [
          "c32108cc-7b73-4921-9f9e-54b3d60c1c6e"
        ],
        "spl_set_id": [
          "f0b78db9-a38c-41bb-8233-5e93f7f18c5c"
        ],
        "package_ndc": [
          "0703-0110-01",
          "0703-0110-03",
          "0703-0113-01",
          "0703-0113-03",
          "0703-0018-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0307030110038"
        ],
        "unii": [
          "L960UP2KRW"
        ]
      },
      "product_type": "Drugs",
      "event_id": "79114",
      "recalling_firm": "Pfizer Inc.",
      "address_1": "235 E 42nd St",
      "address_2": "",
      "postal_code": "10017-5703",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0596-2018",
      "product_description": "Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618. NDC: 0703-0110-01",
      "product_quantity": "53600 vials",
      "reason_for_recall": "Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.",
      "recall_initiation_date": "20180207",
      "center_classification_date": "20180314",
      "termination_date": "20190807",
      "report_date": "20180321",
      "code_info": "Lots # 691853F, EXP. 9/1/2018; 700753F, EXP. 10/1/2018.",
      "more_code_info": ""
    }
  ]
}