{
  "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": "Ongoing",
      "city": "Bengaluru",
      "state": "N/A",
      "country": "India",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA207522"
        ],
        "brand_name": [
          "METHOCARBAMOL"
        ],
        "generic_name": [
          "METHOCARBAMOL"
        ],
        "manufacturer_name": [
          "Somerset Therapeutics, LLC"
        ],
        "product_ndc": [
          "70069-101"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS"
        ],
        "substance_name": [
          "METHOCARBAMOL"
        ],
        "rxcui": [
          "238175"
        ],
        "spl_id": [
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        ],
        "spl_set_id": [
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        ],
        "package_ndc": [
          "70069-101-25",
          "70069-101-10",
          "70069-101-05"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0370069101018",
          "0370069101100",
          "0370069101254",
          "0370069101056"
        ],
        "nui": [
          "N0000175730",
          "N0000175737"
        ],
        "pharm_class_pe": [
          "Centrally-mediated Muscle Relaxation [PE]"
        ],
        "pharm_class_epc": [
          "Muscle Relaxant [EPC]"
        ],
        "unii": [
          "125OD7737X"
        ]
      },
      "product_type": "Drugs",
      "event_id": "96569",
      "recalling_firm": "Somerset Therapeutics Private Limited",
      "address_1": "54/1 Budihal Village",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S. Nationwide",
      "recall_number": "D-0354-2025",
      "product_description": "Methocarbamol Injection USP\t1,000 mg/10 mL (100 mg/mL), 10 mL Single Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-101-25 (immediate carton) and 70069-101-05 (5x10 mL carton)",
      "product_quantity": "506,080 vials",
      "reason_for_recall": "Lack of Assurance of Sterility: Media fill with bacterial contamination",
      "recall_initiation_date": "20250321",
      "center_classification_date": "20250408",
      "report_date": "20250416",
      "code_info": "NDC 70069-101-25; A240304, A240305, A240320, A240322, A240334, A240335, A240340, exp. date 05/2026;  A240342, A240347, A240385, A240391, exp. date 06/2026;   NDC 70069-101-05;  A240326, exp. date 05/2026"
    }
  ]
}