{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Montvale",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA078925"
        ],
        "brand_name": [
          "AMLODIPINE BESYLATE"
        ],
        "generic_name": [
          "AMLODIPINE BESYLATE"
        ],
        "manufacturer_name": [
          "Ascend Laboratories, LLC"
        ],
        "product_ndc": [
          "67877-197",
          "67877-198",
          "67877-199"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "AMLODIPINE BESYLATE"
        ],
        "rxcui": [
          "197361",
          "308135",
          "308136"
        ],
        "spl_id": [
          "9fb4b641-2b16-4bcb-89de-d8d5893916ec"
        ],
        "spl_set_id": [
          "3f4703c0-0b9e-41a0-8b70-da26683d9ed2"
        ],
        "package_ndc": [
          "67877-197-90",
          "67877-197-05",
          "67877-197-10",
          "67877-197-38",
          "67877-198-90",
          "67877-198-05",
          "67877-198-10",
          "67877-198-38",
          "67877-199-90",
          "67877-199-05",
          "67877-199-10",
          "67877-199-38"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "864V2Q084H"
        ]
      },
      "product_type": "Drugs",
      "event_id": "77948",
      "recalling_firm": "Ascend Laboratories LLC",
      "address_1": "180 Summit Ave Ste 200",
      "address_2": "N/A",
      "postal_code": "07645-1722",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA.",
      "recall_number": "D-1134-2017",
      "product_description": "AMLODIPINE BESYLATE TABLET, USP, 10 mg, 1000 count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC Montvale, NJ 07645, NDC 67877-199-10",
      "product_quantity": "1212 bottles",
      "reason_for_recall": "PRESENCE OF FOREIGN TABLETS/CAPSULES:  A 2.5 mg Amlodipine Besylate tablet was found co-mingled with 10 mg Amlodipine Besylate tablets in a bottle labeled as Amlodipine Besylate 10 mg.",
      "recall_initiation_date": "20170505",
      "center_classification_date": "20170911",
      "termination_date": "20180425",
      "report_date": "20170920",
      "code_info": "Lot #: 6142626, Exp 09/19"
    }
  ]
}