{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "25563",
      "product_res_number": "Z-0683-03",
      "event_date_initiated": "2002-12-13",
      "event_date_posted": "2003-03-26",
      "recall_status": "Terminated",
      "event_date_terminated": "2003-05-08",
      "res_event_number": "25298",
      "product_code": "LCH",
      "k_numbers": [
        "K990516"
      ],
      "product_description": "Ethanol Standard, 1.5mg Ethanol in 1 mL.  Product size configuration:  1 mL glass ampule shipped 10 ampules per case.",
      "code_info": "Item # 68996/95 Lot #1295; Exp. Date April 30,2004",
      "firm_fei_number": "2244894",
      "recalling_firm": "EMD Chemicals Inc",
      "address_1": "480 Democrat Road",
      "city": "Gibbstown",
      "state": "NJ",
      "postal_code": "08027",
      "additional_info_contact": "Anna Bentley\n856-423-6300",
      "reason_for_recall": "The Ethanol Standard is OOS on the high end.  The results were 1.58 mg/mL while the specification is 1.477-1.538 mg/mL.",
      "root_cause_description": "Other",
      "action": "All customers were nofitied by phone and letter.  The first notification occurred on 12/17/2002 followed with additional notifications on 1/24/2003, 1/28/2003, and 2/4/2003.",
      "product_quantity": "279 cases of 10 ampules",
      "distribution_pattern": "The Ethanol Products were distributed nationwide by the following distributors:\n\nVWR International, 1310 Goshen Pkwy, West Chester, PA 19380;\nGovernment Scientific, 8460 K-Tyco Road, Vienna, VA 22182;\nAllegiance Healthcare, 1430 Waukegan Rd., McGaw Park, IL 60085;\nFisher Scientific, 2000 Park Lane, Pittsburgh, PA 15275;\nHawaii Chemical Co., 2363 North King Street, Honolulu, HI 96819;\nKrackeler Scientific Inc., 57 Broadway, Albany, NY 12202;\nMidland Scientific Inc., 1202 South 11th St., Omaha, NE 68108;\nReagents, Inc. 4746 Sweden Rd., Charlotte, NC 28224.\n\nThe Papanicolaou Stain was distributed nationwide by the following distributors:\n\nVWR International, 1310 Goshen Pkwy, West Chester, PA 19380;\nFisher Scientific, 2000 Park Lane, Pittsburgh, PA 15275;\nKramer Scientific, 711 Executive Blvd, Valley Cottage, NY  10989;\nLaboratory Supply Company, 3069 Mercury Rd., Jacksonville, FL 32207;\nAllegiance Healthcare, 1430 Waukegan Rd., McGaw Park, IL 60085;\nInfolab, 3000 Greenhill Dr., Round Rock, TX 78664;\nGovernment Scientific, 8460 K-Tyco Road, Vienna, VA  22182.",
      "openfda": {
        "k_number": [
          "K781417",
          "K781386",
          "K841089",
          "K904163",
          "K802379",
          "K862958",
          "K900819",
          "K801599",
          "K922386"
        ],
        "registration_number": [
          "3020756",
          "3013846070",
          "3011898560"
        ],
        "fei_number": [
          "3020756",
          "3013846070",
          "3011898560"
        ],
        "device_name": "Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1660",
        "device_class": "1"
      }
    }
  ]
}