{
  "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,
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  "results": [
    {
      "status": "Ongoing",
      "city": "Verna",
      "state": "N/A",
      "country": "India",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA211711"
        ],
        "brand_name": [
          "CLOBAZAM"
        ],
        "generic_name": [
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        "manufacturer_name": [
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          "42571-316"
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        "product_type": [
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        ],
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          "42571-315-91",
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          "42571-316-30",
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          "M0002356",
          "N0000182137",
          "N0000185506"
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        ],
        "pharm_class_cs": [
          "Benzodiazepines [CS]"
        ],
        "pharm_class_moa": [
          "Cytochrome P450 2D6 Inhibitors [MoA]",
          "Cytochrome P450 3A4 Inducers [MoA]"
        ],
        "unii": [
          "2MRO291B4U"
        ]
      },
      "product_type": "Drugs",
      "event_id": "93975",
      "recalling_firm": "Micro Labs Limited",
      "address_1": "Plot# S - 155",
      "address_2": "& N1 Phase Iii & Phase Iv; Verna Ind Estate Road",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0348-2024",
      "product_description": "Clobazam Tablets 10mg, 100-count bottle, Rx Only, Manufactured by: Micro Labs Limited Goa-403 722, India. Manufactured for: Micro Labs USA, Inc. Somerset, NJ 08873. NDC 42571-315-01",
      "product_quantity": "24,768 bottles",
      "reason_for_recall": "CGMP Deviations: Out of specification for residual solvents.",
      "recall_initiation_date": "20240212",
      "center_classification_date": "20240222",
      "report_date": "20240228",
      "code_info": "ZOAG043"
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}