{
  "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": "Bridgewater",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA020062"
        ],
        "brand_name": [
          "CARDIZEM CD"
        ],
        "generic_name": [
          "DILTIAZEM HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Bausch Health US LLC"
        ],
        "product_ndc": [
          "0187-0795",
          "0187-0796",
          "0187-0797",
          "0187-0798",
          "0187-0799"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DILTIAZEM HYDROCHLORIDE"
        ],
        "rxcui": [
          "830795",
          "830798",
          "830801",
          "830803",
          "830837",
          "830839",
          "830845",
          "830847",
          "830861",
          "830863"
        ],
        "spl_id": [
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        "spl_set_id": [
          "1042fa13-e6af-46b9-8008-6c941f0978b1"
        ],
        "package_ndc": [
          "0187-0795-30",
          "0187-0795-42",
          "0187-0795-49",
          "0187-0796-30",
          "0187-0796-42",
          "0187-0796-49",
          "0187-0796-50",
          "0187-0797-30",
          "0187-0797-42",
          "0187-0797-49",
          "0187-0798-30",
          "0187-0798-42",
          "0187-0799-42"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0301870796421"
        ],
        "unii": [
          "OLH94387TE"
        ]
      },
      "product_type": "Drugs",
      "event_id": "82021",
      "recalling_firm": "Valeant Pharmaceuticals North America LLC",
      "address_1": "400 Somerset Corporate Blvd",
      "address_2": "N/A",
      "postal_code": "08807-2867",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA and Puerto Rico",
      "recall_number": "D-0488-2019",
      "product_description": "Cardizem CD (diltiazem HCl) capsules, 180 mg, packaged in a) 30-count bottles (NDC 0187-0796-30); and b) 90-count bottles (NDC 0187-0796-42), Rx Only, Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA; By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7, Canada.",
      "product_quantity": "206 bottles",
      "reason_for_recall": "Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.",
      "recall_initiation_date": "20190130",
      "center_classification_date": "20190214",
      "termination_date": "20200708",
      "report_date": "20190220",
      "code_info": "Lots: a) 18J018P, Exp 08/2020; b) 18J029P, Exp 08/2020"
    }
  ]
}