{
  "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,
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    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Whitehouse Station",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA022044"
        ],
        "brand_name": [
          "JANUMET"
        ],
        "generic_name": [
          "SITAGLIPTIN AND METFORMIN HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Merck Sharp & Dohme LLC"
        ],
        "product_ndc": [
          "0006-0575",
          "0006-0577"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SITAGLIPTIN PHOSPHATE",
          "METFORMIN HYDROCHLORIDE"
        ],
        "rxcui": [
          "861771",
          "861821",
          "2709488",
          "2709491"
        ],
        "spl_id": [
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        ],
        "spl_set_id": [
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        "package_ndc": [
          "0006-0575-82",
          "0006-0575-61",
          "0006-0575-62",
          "0006-0575-01",
          "0006-0575-52",
          "0006-0575-56",
          "0006-0575-02",
          "0006-0575-03",
          "0006-0577-61",
          "0006-0577-62",
          "0006-0577-82",
          "0006-0577-01",
          "0006-0577-52",
          "0006-0577-56",
          "0006-0577-02",
          "0006-0577-03"
        ],
        "is_original_packager": [
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        ],
        "upc": [
          "0300060575617",
          "0300060577611"
        ],
        "unii": [
          "786Z46389E",
          "TS63EW8X6F"
        ]
      },
      "product_type": "Drugs",
      "event_id": "89893",
      "recalling_firm": "MERCK SHARP & DOHME CORP",
      "address_1": "1 Merck Dr",
      "address_2": "",
      "postal_code": "08889-3400",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0746-2022",
      "product_description": "Janumet (sitagliptin and metformin HCl) tablets, 50 mg/500 mg, 14-count bottle, packaged as 2 bottles per carton , Sample-Not For Sale, Rx Only, Manufactured for Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ 08889, USA, by Patheon Puerto Rico, Inc. Manati, Puerto Rico, 00674  Bottle (NDC 0006-0575-02), Carton (NDC 0006-0575-03)",
      "product_quantity": "3600 cartons",
      "reason_for_recall": "Presence of foreign substance: Presence of stainless steel particulates in tablets.",
      "recall_initiation_date": "20220331",
      "center_classification_date": "20220405",
      "termination_date": "20230815",
      "report_date": "20220413",
      "code_info": "Lot: U015824, Exp. 09/22.",
      "more_code_info": ""
    }
  ]
}