{
  "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": "North Wales",
      "state": "PA",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA060711"
        ],
        "brand_name": [
          "PENICILLIN V POTASSIUM"
        ],
        "generic_name": [
          "PENICILLIN V POTASSIUM"
        ],
        "manufacturer_name": [
          "Teva Pharmaceuticals USA, Inc."
        ],
        "product_ndc": [
          "0093-1172",
          "0093-1174",
          "0093-4125",
          "0093-4127"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "PENICILLIN V POTASSIUM"
        ],
        "rxcui": [
          "834040",
          "834046",
          "834061",
          "834102"
        ],
        "spl_id": [
          "165377dd-4272-4194-9d0b-36d213498f26"
        ],
        "spl_set_id": [
          "3111ca84-6f8e-45ea-91a1-9cb99c63607e"
        ],
        "package_ndc": [
          "0093-1172-01",
          "0093-1172-10",
          "0093-1174-01",
          "0093-1174-10",
          "0093-4125-73",
          "0093-4125-74",
          "0093-4127-73",
          "0093-4127-74"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0300934127737",
          "0300934125733",
          "0300931172013"
        ],
        "unii": [
          "146T0TU1JB"
        ]
      },
      "product_type": "Drugs",
      "event_id": "78641",
      "recalling_firm": "Teva Pharmaceuticals USA",
      "address_1": "1090 Horsham Rd",
      "address_2": "N/A",
      "postal_code": "19454-1505",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA and Puerto Rico.",
      "recall_number": "D-0108-2018",
      "product_description": "Penicillin V Potassium for Oral Solution, USP, 125 mg (200,000 U) per 5 mL, 100 mL (when mixed) bottle, Rx only, Manufactured In Canada By: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454; NDC 0093-4125-73.",
      "product_quantity": "42,384 bottles",
      "reason_for_recall": "Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities.",
      "recall_initiation_date": "20171128",
      "center_classification_date": "20171213",
      "termination_date": "20180703",
      "report_date": "20171220",
      "code_info": "Lot # 35433115A, Exp 01/18"
    }
  ]
}