{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Mahwah",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA212317"
        ],
        "brand_name": [
          "DILTIAZEM HYDROCHLORIDE"
        ],
        "generic_name": [
          "DILTIAZEM HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Northstar Rx LLC"
        ],
        "product_ndc": [
          "16714-553",
          "16714-554",
          "16714-555"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DILTIAZEM HYDROCHLORIDE"
        ],
        "rxcui": [
          "830865",
          "830869",
          "830872"
        ],
        "spl_id": [
          "9835b0d9-56df-4ebd-b5ac-987f38b48741"
        ],
        "spl_set_id": [
          "e2511ffe-5821-4f64-a469-f8ef9618b1b5"
        ],
        "package_ndc": [
          "16714-553-01",
          "16714-554-01",
          "16714-555-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0316714555010",
          "0316714553016",
          "0316714554013"
        ],
        "unii": [
          "OLH94387TE"
        ]
      },
      "product_type": "Drugs",
      "event_id": "95660",
      "recalling_firm": "Glenmark Pharmaceuticals Inc., USA",
      "address_1": "750 Corporate Dr",
      "address_2": "",
      "postal_code": "07430-2009",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0097-2025",
      "product_description": "Diltiazem Hydrochloride Extended-Release Capsules, USP 90mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh India, NDC 16714-554-01.",
      "product_quantity": "4704 bottles",
      "reason_for_recall": "cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.",
      "recall_initiation_date": "20241101",
      "center_classification_date": "20241203",
      "report_date": "20241211",
      "code_info": "Lot #: 17222452, Exp Date 11/30/2024; 17230607, Exp Date 02/28/2025.",
      "more_code_info": ""
    }
  ]
}