{
  "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": [
          "ANDA078720"
        ],
        "brand_name": [
          "AMANTADINE HCL"
        ],
        "generic_name": [
          "AMANTADINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "AvPAK"
        ],
        "product_ndc": [
          "50268-069"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "AMANTADINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "849389"
        ],
        "spl_id": [
          "38566e1f-b7b1-540f-e063-6394a90a2760"
        ],
        "spl_set_id": [
          "461e6444-189e-62ed-6c61-1c36a04459c6"
        ],
        "package_ndc": [
          "50268-069-11",
          "50268-069-15"
        ],
        "original_packager_product_ndc": [
          "69452-142"
        ],
        "unii": [
          "M6Q1EO9TD0"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98449",
      "recalling_firm": "AvKARE",
      "address_1": "615 N 1st St",
      "address_2": "N/A",
      "postal_code": "38478-2403",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA.",
      "recall_number": "D-0341-2026",
      "product_description": "Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-069-15.",
      "product_quantity": "N/A",
      "reason_for_recall": "Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.",
      "recall_initiation_date": "20260213",
      "center_classification_date": "20260223",
      "report_date": "20260304",
      "code_info": "Lot # 49261, Exp: 04/30/27"
    }
  ]
}