{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Hauppauge",
      "state": "NY",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA077073"
        ],
        "brand_name": [
          "AMLODIPINE BESYLATE"
        ],
        "generic_name": [
          "AMLODIPINE BESYLATE"
        ],
        "manufacturer_name": [
          "Cipla USA Inc."
        ],
        "product_ndc": [
          "69097-126",
          "69097-127",
          "69097-128"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "AMLODIPINE BESYLATE"
        ],
        "rxcui": [
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          "308135",
          "308136"
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        "spl_set_id": [
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        "package_ndc": [
          "69097-126-05",
          "69097-126-15",
          "69097-127-05",
          "69097-127-15",
          "69097-128-05",
          "69097-128-15",
          "3690971281"
        ],
        "is_original_packager": [
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        ],
        "upc": [
          "0369097126056",
          "0369097128050",
          "0369097127053",
          "369097128159"
        ],
        "unii": [
          "864V2Q084H"
        ]
      },
      "product_type": "Drugs",
      "event_id": "81099",
      "recalling_firm": "InvaGen Pharmaceuticals, Inc.",
      "address_1": "7 Oser Ave",
      "address_2": "",
      "postal_code": "11788-3811",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide with the United States",
      "recall_number": "D-0012-2019",
      "product_description": "Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc. 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise FL 33323  UPC 369097128159, NDC 69097-128-15",
      "product_quantity": "2880 bottles",
      "reason_for_recall": "Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 month  long term stability condition.",
      "recall_initiation_date": "20181003",
      "center_classification_date": "20181011",
      "termination_date": "20210713",
      "report_date": "20181017",
      "code_info": "Lot #: GG80218, Exp. 12/2019",
      "more_code_info": ""
    }
  ]
}