{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Pennington",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA078899"
        ],
        "brand_name": [
          "BROMOCRIPTINE MESYLATE"
        ],
        "generic_name": [
          "BROMOCRIPTINE MESYLATE"
        ],
        "manufacturer_name": [
          "Zydus Pharmaceuticals USA Inc."
        ],
        "product_ndc": [
          "68382-110"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "BROMOCRIPTINE MESYLATE"
        ],
        "rxcui": [
          "197412"
        ],
        "spl_id": [
          "b9165827-6509-4d3c-813a-547929b720da"
        ],
        "spl_set_id": [
          "d69003ee-0b6f-47a9-834e-ba59c02f566c"
        ],
        "package_ndc": [
          "68382-110-06",
          "68382-110-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "FFP983J3OD"
        ]
      },
      "product_type": "Drugs",
      "event_id": "74233",
      "recalling_firm": "Zydus Pharmaceuticals USA Inc",
      "address_1": "73 Route 31 N",
      "address_2": "",
      "postal_code": "08534-3601",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide",
      "recall_number": "D-1491-2016",
      "product_description": "Bromocriptine Mesylate Capsules USP, 5 mg, 30-count bottles, Rx only, Manufactured by: Cadila Healthcare ltd., Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-110-06",
      "product_quantity": "14,808 bottles",
      "reason_for_recall": "Failed impurities/degradation specifications: Out of specification results noticed in related substance test during analysis of 24 months long term (25 degree Celsius /65% RH) stability samples of two batches.",
      "recall_initiation_date": "20160509",
      "center_classification_date": "20160902",
      "termination_date": "20180501",
      "report_date": "20160914",
      "code_info": "Lot # MP993, Exp10/16; MR2704, Exp 02/17;  MR6851, MR8100; Exp 07/17 and MR1210, Exp 12/17",
      "more_code_info": ""
    }
  ]
}