{
  "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": "2026-07-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Allegan",
      "state": "MI",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "M012"
        ],
        "brand_name": [
          "CAREONE SEVERE CONGESTION NASAL"
        ],
        "generic_name": [
          "OXYMETAZOLINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "American Sales Company"
        ],
        "product_ndc": [
          "41520-108"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "NASAL"
        ],
        "substance_name": [
          "OXYMETAZOLINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1000990"
        ],
        "spl_id": [
          "978439ab-6968-4f1b-a2b0-4247f11e265a"
        ],
        "spl_set_id": [
          "d1dba68b-c4e1-4afc-9aee-6a51341b89f5"
        ],
        "package_ndc": [
          "41520-108-10"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "K89MJ0S5VY"
        ]
      },
      "product_type": "Drugs",
      "event_id": "88905",
      "recalling_firm": "Perrigo Company PLC",
      "address_1": "515 Eastern Ave",
      "address_2": "",
      "postal_code": "49010-9070",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0607-2022",
      "product_description": "Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle,  DISTRIBUTED BY FOODHOLD U.S.A., LLC, LANDOVER, MD 20785. NDC 41520-108-10",
      "product_quantity": "3,192 bottles",
      "reason_for_recall": "CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.",
      "recall_initiation_date": "20211026",
      "center_classification_date": "20220223",
      "termination_date": "20230929",
      "report_date": "20220302",
      "code_info": "Batch: 1BK0716; Exp 12/31/2022); 1FK1251, Exp 02/28/2023",
      "more_code_info": ""
    }
  ]
}