{
  "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": "Plainsboro",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA206884"
        ],
        "brand_name": [
          "AMLODIPINE AND OLMESARTAN MEDOXOMIL"
        ],
        "generic_name": [
          "AMLODIPINE AND OLMESARTAN MEDOXOMIL"
        ],
        "manufacturer_name": [
          "Macleods Pharmaceuticals Limited"
        ],
        "product_ndc": [
          "33342-190",
          "33342-191",
          "33342-192",
          "33342-193"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "AMLODIPINE BESYLATE",
          "OLMESARTAN MEDOXOMIL"
        ],
        "rxcui": [
          "730861",
          "730866",
          "730869",
          "730872"
        ],
        "spl_id": [
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        "spl_set_id": [
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        ],
        "package_ndc": [
          "33342-190-07",
          "33342-190-10",
          "33342-190-12",
          "33342-190-44",
          "33342-191-07",
          "33342-191-10",
          "33342-191-12",
          "33342-191-44",
          "33342-192-07",
          "33342-192-10",
          "33342-192-12",
          "33342-192-44",
          "33342-193-07",
          "33342-193-10",
          "33342-193-12",
          "33342-193-44"
        ],
        "is_original_packager": [
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        ],
        "upc": [
          "0333342192073",
          "0333342191076",
          "0333342192103",
          "0333342190079",
          "0333342193100",
          "0333342191106",
          "0333342193070",
          "0333342190109"
        ],
        "unii": [
          "864V2Q084H",
          "6M97XTV3HD"
        ]
      },
      "product_type": "Drugs",
      "event_id": "89600",
      "recalling_firm": "Macleods Pharma Usa Inc",
      "address_1": "666 Plainsboro Rd Bldg 200 Ste 230",
      "address_2": "",
      "postal_code": "08536-0009",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "USA Nationwide",
      "recall_number": "D-0632-2022",
      "product_description": "Amlodipine and Olmesartan Medoxomil Tablets, 10 mg /20 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals, Ltd, Baddi, Himachal Pradesh, INDIA, NDC 33342-192-07.",
      "product_quantity": "3,672 bottles",
      "reason_for_recall": "cGMP deviations",
      "recall_initiation_date": "20220215",
      "center_classification_date": "20220225",
      "termination_date": "20230217",
      "report_date": "20220309",
      "code_info": "Lot#: BAD62101A, Exp 2/2024",
      "more_code_info": ""
    }
  ]
}