{
  "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": "2026-05-06",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Plymouth Meeting",
      "state": "PA",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "brand_name": [
          "MONSELS SOLUTION"
        ],
        "generic_name": [
          "FERRIC SUBSULFATE"
        ],
        "manufacturer_name": [
          "Premier Dental Products Company"
        ],
        "product_ndc": [
          "48783-112"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "FERRIC SUBSULFATE"
        ],
        "spl_id": [
          "4847c0c4-f60a-2f71-e063-6294a90a5830"
        ],
        "spl_set_id": [
          "7a9923af-b8ed-4dc5-b6ae-2f42f83eb3db"
        ],
        "package_ndc": [
          "48783-112-08"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "3QJ8WS6V8H"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98775",
      "recalling_firm": "Premier Dental Products Co",
      "address_1": "1710 Romano Dr",
      "address_2": "N/A",
      "postal_code": "19462-2822",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0490-2026",
      "product_description": "Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Premier Medical Products, 1710 Romano Drive, Plymouth Meeting, PA 19462, NDC 48783-112-08.",
      "product_quantity": "573 cartons",
      "reason_for_recall": "Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14). It is important to note that this error is limited to the vial itself; the saleable unit of the box of 12 bottles has the correct expiration date printed.",
      "recall_initiation_date": "20260414",
      "center_classification_date": "20260424",
      "report_date": "20260429",
      "code_info": "Lot #: 640911253, Exp Date. 09/14/2027.",
      "more_code_info": ""
    }
  ]
}