{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Hauppauge",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "M012"
        ],
        "brand_name": [
          "SEVERE COLD AND FLU PLUS CONGESTION"
        ],
        "generic_name": [
          "ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL"
        ],
        "manufacturer_name": [
          "COSTCO WHOLESALE CORPORATION"
        ],
        "product_ndc": [
          "63981-795"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "rxcui": [
          "1110988",
          "1546881",
          "2634817"
        ],
        "spl_id": [
          "e41815f0-2c46-472a-9b9c-6c20653fc014"
        ],
        "spl_set_id": [
          "5180abbc-c6c4-4b82-b6e7-4504e3bcff0f"
        ],
        "package_ndc": [
          "63981-795-81"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0196633991997"
        ]
      },
      "product_type": "Drugs",
      "event_id": "95773",
      "recalling_firm": "LNK International, Inc.",
      "address_1": "22 Arkay Dr",
      "address_2": "",
      "postal_code": "11788-3708",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Product was distributed to 1 wholesale retail customer who may have further distribute the product nationwide.",
      "recall_number": "D-0115-2025",
      "product_description": "Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets blister pack; (Acetaminophen 325mg, Dextromethorphan HBr 10 mg, Guaifenesin 200 mg, Phenylephrine HCl 5 mg); Night - 56 coated caplets blister pack; (Acetaminophen 325mg, Dextromethorphan HBr 10 mg, Doxylamine succinate 6.25 mg, Phenylephrine HCl 5 mg); Manufactured BY: LNK International, Inc. FOR: Costco Wholesale Corporation. NDC# 63981-795-81",
      "product_quantity": "288 cases x 30  8,640 boxes",
      "reason_for_recall": "CGMP Deviations: Released product should have been rejected.",
      "recall_initiation_date": "20241114",
      "center_classification_date": "20241209",
      "termination_date": "20250902",
      "report_date": "20241218",
      "code_info": "Lot # P139953, exp. date 2026/AUG Lot # P139815, exp. date 2026/AUG",
      "more_code_info": ""
    }
  ]
}