{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Grand Rapids",
      "state": "MI",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "brand_name": [
          "NEORELIEF FOR MUSCLE CRAMPLING AND RESTLESSNESS"
        ],
        "generic_name": [
          "TOPICAL GEL FOR MUSCLE CRAMPING AND RESTLESSNESS"
        ],
        "manufacturer_name": [
          "BioLyte Laboratories, LLC"
        ],
        "product_ndc": [
          "58368-002"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ARNICA MONTANA",
          "ARTEMISIA CINA PRE-FLOWERING TOP",
          "ATROPA BELLADONNA ROOT",
          "BLACK COHOSH",
          "CAUSTICUM",
          "FRANGULA CALIFORNICA BARK",
          "HYPERICUM PERFORATUM",
          "JATROPHA CURCAS SEED",
          "LYCOPODIUM CLAVATUM SPORE",
          "POTASSIUM BROMIDE",
          "POTASSIUM CARBONATE",
          "PSEUDOGNAPHALIUM OBTUSIFOLIUM",
          "RUTA GRAVEOLENS FLOWERING TOP",
          "SCUTELLARIA LATERIFLORA",
          "STRYCHNOS IGNATII SEED",
          "TARAXACUM OFFICINALE",
          "VALERIAN",
          "VERATRUM ALBUM ROOT"
        ],
        "spl_id": [
          "4960b345-0a8e-7316-e063-6394a90abe8f"
        ],
        "spl_set_id": [
          "46da3f0e-9dd1-6495-e054-00144ff8d46c"
        ],
        "package_ndc": [
          "58368-002-02"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "O80TY208ZW",
          "28M1820ACT",
          "6MW97Q6E8M",
          "K73E24S6X9",
          "DD5FO1WKFU",
          "1LZ13MQR0S",
          "XK4IUX8MNB",
          "J0F5GM8LA8",
          "C88X29Y479",
          "OSD78555ZM",
          "BQN1B9B9HA",
          "36XQ854NWW",
          "N94C2U587S",
          "7BP4DH5PDC",
          "1NM3M2487K",
          "39981FM375",
          "JWF5YAW3QW",
          "QNS6W5US1Z"
        ]
      },
      "product_type": "Drugs",
      "event_id": "81011",
      "recalling_firm": "BioLyte Laboratories, LLC",
      "address_1": "310 Northern Dr. Nw",
      "address_2": "",
      "postal_code": "49534",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Telephone",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0002-2019",
      "product_description": "NeoRelief for Muscle Cramping & Restlessness Homeopathic Topical Gel, packaged in a) 4 ml sample packs and b) Net Wt. 2.0 oz (56.7g) bottles, BioLyte Laboratories - Grand Rapids, MI 49534, NDC 58368-002-02",
      "product_quantity": "a) 500 sample packs; b) 672 bottles",
      "reason_for_recall": "CGMP Deviations: finished product produced with active ingredients recalled by the manufacturer, King Bio Inc., due to water contamination issues that could potentially affect the quality of this product.",
      "recall_initiation_date": "20180831",
      "center_classification_date": "20181001",
      "termination_date": "20200831",
      "report_date": "20181010",
      "code_info": "Lot #: a) 1146, Exp 3/29/20; b) 1138, 1139, Exp 1/31/20; and 1160, Exp 10/10/19",
      "more_code_info": ""
    }
  ]
}