{
  "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": "East Brunswick",
      "state": "NJ",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "ANDA213324"
        ],
        "brand_name": [
          "CYCLOBENZAPRINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "CYCLOBENZAPRINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Unichem Pharmaceuticals (USA), Inc."
        ],
        "product_ndc": [
          "29300-413",
          "29300-414",
          "29300-415"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CYCLOBENZAPRINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "828299",
          "828320",
          "828348"
        ],
        "spl_id": [
          "cc113cd6-8904-4485-b1b2-15dd5ff7468b"
        ],
        "spl_set_id": [
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        ],
        "package_ndc": [
          "29300-413-05",
          "29300-413-10",
          "29300-413-01",
          "29300-413-19",
          "29300-414-01",
          "29300-414-10",
          "29300-415-01",
          "29300-415-05",
          "29300-415-10",
          "29300-415-19"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "0VE05JYS2P"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97482",
      "recalling_firm": "Unichem Pharmaceuticals USA Inc.",
      "address_1": "1 Tower Center Blvd Ste 2200",
      "address_2": "N/A",
      "postal_code": "08816-1145",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Press Release",
      "distribution_pattern": "Nationwide within the U.S.A",
      "recall_number": "D-0655-2025",
      "product_description": "Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only,    Manufactured by: Unichem Laboratories, Ltd, Pilerne Ind. Estate, Pilerne, Bardez, Goa, India; Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ. NDC 29300-415-19.",
      "product_quantity": "230 90-count bottles",
      "reason_for_recall": "Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color).",
      "recall_initiation_date": "20250827",
      "center_classification_date": "20250917",
      "report_date": "20250924",
      "code_info": "Lot No: GMML24026A, Expires: 09/30/2027"
    }
  ]
}