{
  "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-0061-2021",
      "product_description": "Time-Cap Labs, Inc. Metformin Hydrochloride  Extended-Release Tablets USP 500 mg, a) 90 count (NDC 49483-623-09) b) 100 count (49483-623-01) c) 500 count (NDC 49483-623-50) and d) 1000 count (NDC 49483-623-10) 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 49483-623-50",
      "product_quantity": "a) 64,590 b) 23,834 c) 109,125 d) 27839 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": "a) 90 count:   E072F, E074F, E076F Oct-20; D096F, H029F, H031F,XP8276, XP8289 Nov-20;  L007F, J022F, H039F, Dec-20; J092F Jan-21; L055F Jun-21; K079F Jul-21; A002G, A003G, A007G Aug-21; A49001 Nov-21; A40001, A40003, A40005 Dec-21; A40009 Feb-22; A40010, XP0036, A40013  Mar-22; A40015 Apr-22    b) 100 count:  XP8260 Oct-20; XP0010, XP0016 Dec-21; XP0046 Apr-22;    c) 500 count:  E037F, G011F Oct-20; F001F Nov-20; H041F, L009F Dec-20; K051F Jun-21; A115G, A010G Sep-21; A40006, A40007, A40008 Jan-22; A40011 Mar-22; A40016, A40018 Apr-22;    d) 1000 count:  D086F Oct-20; G012F Nov-20; L008F Dec-20; K042F Feb-21; M001F Jul-21; A009G Sep-21; A40002, A40004 Dec-21; A40012 Mar-22, A40014, A40017 Apr-22"
    }
  ]
}