{
  "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": "Deerfield",
      "state": "IL",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA078950"
        ],
        "brand_name": [
          "METOPROLOL"
        ],
        "generic_name": [
          "METOPROLOL TARTRATE"
        ],
        "manufacturer_name": [
          "Baxter Healthcare Corporation"
        ],
        "product_ndc": [
          "36000-033"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "METOPROLOL TARTRATE"
        ],
        "rxcui": [
          "866508"
        ],
        "spl_id": [
          "5d975af3-d078-4130-9448-ed77123f1aac"
        ],
        "spl_set_id": [
          "09566368-f91d-43a3-b683-30c844fb125a"
        ],
        "package_ndc": [
          "36000-033-10"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0336000033107"
        ],
        "unii": [
          "W5S57Y3A5L"
        ]
      },
      "product_type": "Drugs",
      "event_id": "81353",
      "recalling_firm": "Baxter Healthcare Corporation",
      "address_1": "1 Baxter Pkwy",
      "address_2": "",
      "postal_code": "60015-4625",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distributed nationwide in the USA and Puerto Rico",
      "recall_number": "D-0222-2019",
      "product_description": "Metoprolol Tartrate Injection, USP, 5 mg/ 5 mL (1 mg/mL), 5 mL per sterile single use glass vial, Rx Only, Manufactured for: Claris Lifesciences, Inc., North Brunswick, NJ 08902.  By:  Claris Injectables Ltd., Gujarat, India.  NDC:  36000-033-10",
      "product_quantity": "402,165 vials",
      "reason_for_recall": "Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the impacted lots.",
      "recall_initiation_date": "20181015",
      "center_classification_date": "20181107",
      "termination_date": "20220812",
      "report_date": "20181114",
      "code_info": "Lot #S: A061267, A061273,EXP 10/2018; A061392, A061395, A061398, A061403, A061407, EXP 11/2018; A0A0070, A0A0073, A0A0079, A0A0081, A0A0083, EXP 12/2018; A0A0119, A0A0124, A0A0125, A0A0133, A0A0141, A0A0145, A0A0152, EXP 1/2019; A0A0247, A0A0252, A0A0253, A0A0292, A0A0293, EXP 2/2019; A0A0361, A0A0367, A0A0390, EXP 3/2019; A0A0438, A0A0445, A0A0453, A0A0459, EXP 4/2019; A0A0547, A0A0551, A0A0554, A0A0630, A0A0631, A0A0637, A0A0638, EXP 5/2019; A0A0777, EXP 7/2019; A0A0915, A0A0919, A0A0924, A0A0930, EXP 8/2019; A0A1094, A0A1097, A0A1110, EXP 11/2019;",
      "more_code_info": ""
    }
  ]
}