{
  "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": "Lincoln",
      "state": "RI",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "M002"
        ],
        "brand_name": [
          "LITTLE REMEDIES"
        ],
        "generic_name": [
          "SIMTHICONE"
        ],
        "manufacturer_name": [
          "Medtech Products Inc."
        ],
        "product_ndc": [
          "63029-103"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DIMETHICONE"
        ],
        "rxcui": [
          "198857"
        ],
        "spl_id": [
          "d8d1cb22-3ce5-47fb-8795-abca27175110"
        ],
        "spl_set_id": [
          "874d3f1d-1e4a-49ab-8285-4d6bf2601d5e"
        ],
        "package_ndc": [
          "63029-103-01",
          "63029-103-02"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000010282"
        ],
        "pharm_class_pe": [
          "Skin Barrier Activity [PE]"
        ],
        "unii": [
          "92RU3N3Y1O"
        ]
      },
      "product_type": "Drugs",
      "event_id": "94712",
      "recalling_firm": "Denison Pharmaceuticals, LLC",
      "address_1": "1 Powder Hill Rd",
      "address_2": "N/A",
      "postal_code": "02865-4407",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "N/A",
      "distribution_pattern": "Recalled units were distributed to one customer. 100% recovered (113,544 units) and controlled at Denison Pharmaceuticals.",
      "recall_number": "D-0557-2024",
      "product_description": "Little Remedies Gas Relief Drops (Simethicone/Antigas), packaged in 1 fl. oz. (30 mL) bottle with dropper, Dist by Medtech Products Inc., Tarrytown, NY 10591, NDC 63029-103-02",
      "product_quantity": "113,544 bottles",
      "reason_for_recall": "cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.",
      "recall_initiation_date": "20240528",
      "center_classification_date": "20240617",
      "termination_date": "20250826",
      "report_date": "20240626",
      "code_info": "Lot #: 0855, Exp. 8/31/ 2025"
    }
  ]
}