{
  "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": "Terminated",
      "city": "Plainsboro",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA203533"
        ],
        "brand_name": [
          "RISEDRONATE SODIUM"
        ],
        "generic_name": [
          "RISEDRONATE SODIUM"
        ],
        "manufacturer_name": [
          "Macleods Pharmaceuticals Limited"
        ],
        "product_ndc": [
          "33342-107",
          "33342-108",
          "33342-109"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "RISEDRONATE SODIUM"
        ],
        "rxcui": [
          "905024",
          "905032",
          "905041",
          "905092",
          "905100"
        ],
        "spl_id": [
          "56e83e0f-83f7-4039-a9b2-0d5ae251e2b1"
        ],
        "spl_set_id": [
          "62aff8d6-a2f7-4c7e-a102-c70105ac3792"
        ],
        "package_ndc": [
          "33342-107-07",
          "33342-107-49",
          "33342-107-06",
          "33342-108-07",
          "33342-108-15",
          "33342-108-06",
          "33342-109-37",
          "33342-109-50"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "OFG5EXG60L"
        ]
      },
      "product_type": "Drugs",
      "event_id": "89766",
      "recalling_firm": "Macleods Pharma Usa Inc",
      "address_1": "666 Plainsboro Rd Bldg 200 Ste 230",
      "address_2": "",
      "postal_code": "08536-0009",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "USA Nationwide",
      "recall_number": "D-0762-2022",
      "product_description": "Risedronate Sodium Tablets, USP, 5 mg, Rx Only, 30-count bottle, Manufactured for: Macleods Pharma USA, Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., BAddi, HImchal Pradesh, INDIA, NDC 33342-107-07.",
      "product_quantity": "4872 bottles",
      "reason_for_recall": "FAILED CONTENT UNIFORMITY SPECIFICATIONS",
      "recall_initiation_date": "20220310",
      "center_classification_date": "20220407",
      "termination_date": "20230629",
      "report_date": "20220413",
      "code_info": "Lot #: BRD2001A, Exp 5/2022",
      "more_code_info": ""
    }
  ]
}