{
  "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": "Massena",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "M012"
        ],
        "brand_name": [
          "OXYMETAZOLINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "OXYMETAZOLINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "CHAIN DRUG MARKETING ASSOCIATION INC."
        ],
        "product_ndc": [
          "63868-605",
          "63868-676"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "NASAL"
        ],
        "substance_name": [
          "OXYMETAZOLINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1000990"
        ],
        "spl_id": [
          "3446fcd3-f2b4-4f5f-b80e-f0600b7efc81"
        ],
        "spl_set_id": [
          "c7b1f980-9b0d-4f63-a70d-fd366658f863"
        ],
        "package_ndc": [
          "63868-605-01",
          "63868-676-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0635515988439",
          "0635515988477",
          "635515988477"
        ],
        "unii": [
          "K89MJ0S5VY"
        ]
      },
      "product_type": "Drugs",
      "event_id": "93708",
      "recalling_firm": "Seaway Pharma Inc.",
      "address_1": "5 County Route 42",
      "address_2": "N/A",
      "postal_code": "13662-1569",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "MI, PA",
      "recall_number": "D-0216-2024",
      "product_description": "Quality Choice No Drip Extra Moisturizing Nasal Pump Mist Oxymetazoline hydrochloride 0.05%, 12 Hour Nasal Decongestant, 1 fl oz (30 mL) bottle, Distributed by C.D.M.A, Inc. 43157 W 9 Mile Rd. Novi, MI 48375, NDC# 63868-676-01, UPC 6-35515-98847-7.",
      "product_quantity": "7,992 bottles",
      "reason_for_recall": "CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.",
      "recall_initiation_date": "20231228",
      "center_classification_date": "20240104",
      "report_date": "20240110",
      "code_info": "Lot # SE23034, Exp 05/31/2026"
    }
  ]
}