{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Vasco Da Gama",
      "state": "N/A",
      "country": "India",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA090295"
        ],
        "brand_name": [
          "METFORMIN HYDROCHLORIDE EXTENDED RELEASE"
        ],
        "generic_name": [
          "METFORMIN HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "TIME CAP LABORATORIES, INC"
        ],
        "product_ndc": [
          "49483-623",
          "49483-624"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "METFORMIN HYDROCHLORIDE"
        ],
        "rxcui": [
          "860975",
          "860981"
        ],
        "spl_id": [
          "4d845f5a-3ab1-b5ac-e063-6394a90a75d6"
        ],
        "spl_set_id": [
          "1d8b8970-c2a1-4780-be87-ab8ccfd401fa"
        ],
        "package_ndc": [
          "49483-623-09",
          "49483-623-01",
          "49483-623-50",
          "49483-623-10",
          "49483-624-01",
          "49483-624-50"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0349483624014",
          "0349483623109",
          "0349483623017"
        ],
        "unii": [
          "786Z46389E"
        ]
      },
      "product_type": "Drugs",
      "event_id": "86530",
      "recalling_firm": "Marksans Pharma Limited",
      "address_1": "& L - 83 Plots L - 82",
      "address_2": "Verna, Goa",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Press Release",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0062-2021",
      "product_description": "Time-Cap Labs, Inc. Metformin Hydrochloride Extended Release Tablets USP 750 mg, 100 count bottles, Rx Only Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue Farmingdale, NY 11735, USA  Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83, Verna Indl. Estate. Verna Goa-403 722 India  NDC 49483-624-01",
      "product_quantity": "368,976 bottles",
      "reason_for_recall": "CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level",
      "recall_initiation_date": "20201002",
      "center_classification_date": "20201102",
      "termination_date": "20240221",
      "report_date": "20201111",
      "code_info": "M125E Oct-20; D001F, C084F Nov-20; F073F, E063F Jan-21; F072F Mar-21; J002F, J087F Apr-21; K080F, L056F Jun 21; M046F, Jul-21; 9R9001, Oct-21;    9R9002, Nov-21; 9R0001, 9R0002 Dec-21; 9R0003, XR0016, 9R0004, 9R0005 Mar-22; 9R0006, 9R0007 Apr-22"
    }
  ]
}