{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "192221",
      "product_res_number": "Z-0856-2022",
      "event_date_initiated": "2022-02-21",
      "event_date_created": "2022-04-04",
      "recall_status": "Terminated",
      "event_date_terminated": "2024-05-15",
      "res_event_number": "89687",
      "product_code": "OLR",
      "k_numbers": [
        "K202000"
      ],
      "product_description": "Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm",
      "code_info": "Product Number: 69420-8351-1\nLot Number: U701SF1\nUDI Code: N/A",
      "firm_fei_number": "3015256319",
      "recalling_firm": "SA3, LLC",
      "address_1": "2317 Cotner Ave",
      "city": "Los Angeles",
      "state": "CA",
      "postal_code": "90064-1803",
      "additional_info_contact": "Farbod Melamed\n310-282-8086",
      "reason_for_recall": "Due to failure of microbial testing for total aerobic microbial count (TAMC).",
      "root_cause_description": "Under Investigation by firm",
      "action": "On 02/21/2022, the firm emailed an Urgent Recall Notification to customers informing them that the recall has been initiated due to the affected lot's microbial testing results for total aerobic microbial count (TAMC exceeded specifications prior to expiry of the gel.\n\nCustomer are instructed to:\n1. Immediately examine your inventory and quarantine product subject to this recall.\n2. Immediately discontinue use and distribution of the identified lot number.\n3. To request a prepaid shipping label, complete and return the enclosed  Customer Market\nWithdrawal Return Response Form via email at info@alexso.com or via fax at 888-502-1669.\n4. If customer have further distributed this product to other wholesalers or pharmacies, please identify and notify them at once of this product market recall. The Recall notification and return response form should be include when notifying these customers.\n5. Return the affected product to:\nAlexso, Inc.\nc/o Recall\n2317 Cotner Ave\nLos Angeles, CA 90064\n\nFor any questions, contact the Recalling Firm at (888)-495-6078, Monday through Friday 9:00 AM to 5:00 PM PST or email at info@alexso.com.\n\nOn 03/07/2022, the firm emailed an updated \"URGENT: Medical Device Market Removal\" letter which informs customers of the potential risks/harms/hazards associated with use of the affected products and added that it is recommended that physicians monitor their patents for potential adverse reactions and events as a result of use of the affected product.",
      "product_quantity": "156 units",
      "distribution_pattern": "U.S. Nationwide distribution in the states of CA, FL and GA.",
      "openfda": {
        "k_number": [
          "K023155",
          "K253758",
          "K260120",
          "K193336",
          "K251908",
          "K953423",
          "K053342",
          "K252425",
          "K983182",
          "K062795",
          "K210211",
          "K103054",
          "K260126",
          "K211851",
          "K060340",
          "K110750",
          "K013056",
          "K183436",
          "K130959",
          "K203091",
          "K063148",
          "K042400",
          "K040950",
          "K230529",
          "K241283",
          "K082856",
          "K070842",
          "K012126",
          "K101769",
          "K042722",
          "K081372",
          "K253816",
          "K964852",
          "K933741",
          "K090612",
          "K082553",
          "K191987",
          "K173196",
          "K202000",
          "K060363",
          "K221428",
          "K024180",
          "K112568"
        ],
        "device_name": "Oral Wound Dressing",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "U",
        "registration_number": [
          "3010864832",
          "3007735241",
          "3016611551",
          "3006497550",
          "3004146122",
          "3004050854",
          "3015528146",
          "2938386",
          "3005488671",
          "8043396",
          "1646434",
          "3019867040",
          "3006619672",
          "3004985762",
          "3010143501",
          "3005488444",
          "9611959",
          "3029906643",
          "3016096134",
          "1424263",
          "2244725",
          "2135339",
          "3013576473",
          "3016505723",
          "3004087544",
          "1450662",
          "3003311293",
          "3012263097",
          "2032542",
          "3011276993",
          "2518467"
        ],
        "fei_number": [
          "3007735241",
          "3016611551",
          "3006497550",
          "3004146122",
          "3002677549",
          "3004050854",
          "3015528146",
          "2938386",
          "3005488671",
          "3007867940",
          "3019867040",
          "3006619672",
          "3003015552",
          "3004985762",
          "3010143501",
          "3005488444",
          "3029906643",
          "3016096134",
          "2244725",
          "1000138377",
          "3013576473",
          "3016505723",
          "3004087544",
          "1450662",
          "3003311293",
          "3003646540",
          "3012263097",
          "3005461046",
          "3011276993",
          "3010862763",
          "2518467"
        ]
      }
    }
  ]
}