{
  "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": "2026-07-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Santa Fe Springs",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "M003"
        ],
        "brand_name": [
          "REVITADERM WOUND CARE"
        ],
        "generic_name": [
          "BENZALKONIUM CHLORIDE"
        ],
        "manufacturer_name": [
          "Blaine Labs Inc."
        ],
        "product_ndc": [
          "63347-120"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "BENZALKONIUM CHLORIDE"
        ],
        "rxcui": [
          "1049228",
          "1310820"
        ],
        "spl_id": [
          "69b73949-a7e7-4e85-911e-ae688d658bbf"
        ],
        "spl_set_id": [
          "9254dada-4e32-43a0-892b-c488d68e23e7"
        ],
        "package_ndc": [
          "63347-120-01",
          "63347-120-02"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "F5UM2KM3W7"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98731",
      "recalling_firm": "Blaine Labs Inc",
      "address_1": "11037 Lockport Pl",
      "address_2": "N/A",
      "postal_code": "90670-4634",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Press Release",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0699-2026",
      "product_description": "Revitaderm Wound Care, First Aid Antiseptic Gel, Benzalkonium Chloride 0.1%) packaged as (a) 1.0 Fl OZ (16 mL) bottle, long pointy cap, NDC 63347-120-02; (b) 3.0 Fl OZ (85 g) tube, with short twist cap, NDC 63347-120-01; Manufactured By: Blaine Labs, Inc. 11037 Lockport Place, Santa Fe Springs, CA 90670,",
      "product_quantity": "5,555 bottles and tubes",
      "reason_for_recall": "CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated",
      "recall_initiation_date": "20260408",
      "center_classification_date": "20260716",
      "report_date": "20260708",
      "code_info": "Lots: (a) 1 oz - BL3435, Exp 11/06/26; BL3525, Exp 08/07/27. (b) 3 oz- Lots # BL3435, 11/06/26 & BL3525, 08/07/27"
    }
  ]
}