{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Pulaski",
      "state": "TN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA207616"
        ],
        "brand_name": [
          "ROSUVASTATIN"
        ],
        "generic_name": [
          "ROSUVASTATIN"
        ],
        "manufacturer_name": [
          "AvPAK"
        ],
        "product_ndc": [
          "50268-709",
          "50268-710",
          "50268-711"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ROSUVASTATIN CALCIUM"
        ],
        "rxcui": [
          "859419",
          "859747",
          "859751"
        ],
        "spl_id": [
          "39ff0f38-7c7a-4ce1-e063-6394a90aa663"
        ],
        "spl_set_id": [
          "7cd6ae8d-aa67-60db-e053-2991aa0a0ede"
        ],
        "package_ndc": [
          "50268-709-11",
          "50268-709-15",
          "50268-710-11",
          "50268-710-15",
          "50268-711-11",
          "50268-711-15"
        ],
        "original_packager_product_ndc": [
          "31722-883",
          "31722-884",
          "31722-885"
        ],
        "unii": [
          "83MVU38M7Q"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98246",
      "recalling_firm": "AvKARE",
      "address_1": "615 N 1st St",
      "address_2": "",
      "postal_code": "38478-2403",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0292-2026",
      "product_description": "Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478.  NDC:  50268-709-15",
      "product_quantity": "7,991 5x10 cartons",
      "reason_for_recall": "Out of specification for dissolution.",
      "recall_initiation_date": "20251231",
      "center_classification_date": "20260120",
      "report_date": "20260114",
      "code_info": "Lot #49124, Exp Date 12/31/2026",
      "more_code_info": ""
    }
  ]
}