{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Santa Fe Springs",
      "state": "CA",
      "country": "United States",
      "classification": "Class I",
      "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": "89481",
      "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": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Nationwide in 17 States to 45 doctors.",
      "recall_number": "D-0668-2022",
      "product_description": "REVITADERM WOUND CARE GEL, (Benzalkonium Chloride in a gel containing transforming growth factor-b), 0.1%, packaged in 29.6 mL (1.0 FL OZ) bottles (NDC 63347-120-02) and 88.7 mL (3.0 FL OZ) tubes (NDC 63347-120-01), Blaine Labs Inc., Santa Fe Springs, CA 90670",
      "product_quantity": "1119 (1 oz.) bottles/ 772 (3 oz.) tubes",
      "reason_for_recall": "Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus.",
      "recall_initiation_date": "20220125",
      "center_classification_date": "20220318",
      "termination_date": "20220801",
      "report_date": "20220330",
      "code_info": "Lot/Batch #: BL 2844, Expiration date 2/19/2023"
    }
  ]
}