{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Montvale",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA091184"
        ],
        "brand_name": [
          "METFORMIN HYDROCHLORIDE"
        ],
        "generic_name": [
          "METFORMIN HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Ascend Laboratories, LLC"
        ],
        "product_ndc": [
          "67877-217",
          "67877-218",
          "67877-221",
          "67877-413",
          "67877-414"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "METFORMIN HYDROCHLORIDE"
        ],
        "rxcui": [
          "860975",
          "860981",
          "861004",
          "861007",
          "861010"
        ],
        "spl_id": [
          "4fa6bd66-7f2c-4b63-9809-be460cbc2527"
        ],
        "spl_set_id": [
          "0ff1ba75-3c86-4baf-a6b1-1bb883839866"
        ],
        "package_ndc": [
          "67877-217-01",
          "67877-217-05",
          "67877-217-10",
          "67877-217-33",
          "67877-217-38",
          "67877-218-01",
          "67877-218-05",
          "67877-218-10",
          "67877-218-33",
          "67877-218-38",
          "67877-221-01",
          "67877-221-05",
          "67877-221-10",
          "67877-221-33",
          "67877-221-38",
          "67877-413-01",
          "67877-413-05",
          "67877-413-10",
          "67877-413-33",
          "67877-413-90",
          "67877-414-01",
          "67877-414-05",
          "67877-414-10",
          "67877-414-33",
          "67877-414-90"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0367877221014",
          "0367877218014",
          "0367877414904",
          "0367877413907"
        ],
        "unii": [
          "786Z46389E"
        ]
      },
      "product_type": "Drugs",
      "event_id": "75698",
      "recalling_firm": "Ascend Laboratories LLC",
      "address_1": "180 Summit Ave Ste 200",
      "address_2": "",
      "postal_code": "07645-1722",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "AL, FL, GA, SC & TN",
      "recall_number": "D-0163-2017",
      "product_description": "Metformin Hydrochloride Tablets, USP 500 mg, 1000 tablets, Rx Only  Manufactured by: Alkem Laboratories Ltd., Mumbai  - 400 013, India, Distributed by: Ascend Laboratories, LLC, Montvale, NJ  NDC 67877-217-10",
      "product_quantity": "1739 bottles",
      "reason_for_recall": "Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP",
      "recall_initiation_date": "20161102",
      "center_classification_date": "20161129",
      "termination_date": "20170607",
      "report_date": "20161207",
      "code_info": "Lot 6121056, exp 5/2019",
      "more_code_info": ""
    }
  ]
}