{
  "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": "2026-07-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Durham",
      "state": "NC",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA078155"
        ],
        "brand_name": [
          "SIMVASTATIN"
        ],
        "generic_name": [
          "SIMVASTATIN"
        ],
        "manufacturer_name": [
          "Accord Healthcare, Inc."
        ],
        "product_ndc": [
          "16729-004",
          "16729-005",
          "16729-006",
          "16729-007",
          "16729-156"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SIMVASTATIN"
        ],
        "rxcui": [
          "198211",
          "200345",
          "312961",
          "312962",
          "314231"
        ],
        "spl_id": [
          "43910ff2-6a21-bf9e-e063-6294a90a3f5c"
        ],
        "spl_set_id": [
          "871251c0-36a1-4a32-9eab-ff6c1e925ca9"
        ],
        "package_ndc": [
          "16729-005-10",
          "16729-005-12",
          "16729-005-15",
          "16729-005-17",
          "16729-006-10",
          "16729-006-12",
          "16729-006-15",
          "16729-006-17",
          "16729-007-10",
          "16729-007-12",
          "16729-007-15",
          "16729-007-17",
          "16729-156-10",
          "16729-156-15",
          "16729-156-17",
          "16729-004-10",
          "16729-004-12",
          "16729-004-15",
          "16729-004-17"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175589",
          "N0000000121"
        ],
        "pharm_class_epc": [
          "HMG-CoA Reductase Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"
        ],
        "unii": [
          "AGG2FN16EV"
        ],
        "upc": [
          "316729156158",
          "316729156172"
        ]
      },
      "product_type": "Drugs",
      "event_id": "91657",
      "recalling_firm": "Accord Healthcare, Inc.",
      "address_1": "1009 Slater Rd Ste 210B",
      "address_2": "N/A",
      "postal_code": "27703-8446",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "United States including Puerto Rico and Canada",
      "recall_number": "D-0408-2023",
      "product_description": "Simvastatin Tablets USP 5 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-156-15, UPC 3 16729 15615 8; b) 1,000-count bottle NDC 16729-156-17, UPC 3 16729 15617 2; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA",
      "product_quantity": "256,648 bottles",
      "reason_for_recall": "CGMP Deviations: recalling drug products following an FDA inspection.",
      "recall_initiation_date": "20230207",
      "center_classification_date": "20230302",
      "termination_date": "20240422",
      "report_date": "20230308",
      "code_info": "Batches: a) R2100818, Exp. Date 6/30/2023; R2100964, Exp. Date 6/30/2023; R2100824, Exp. Date 6/30/2023; R2100820, Exp. Date 6/30/2023; R2100822, Exp. Date 6/30/2023; R2101201, Exp. Date 9/30/2023; R2101198, Exp. Date 9/30/2023; R2101199, Exp. Date 9/30/2023; R2101200, Exp. Date 9/30/2023; R2101355, Exp. Date 10/31/2023; R2200035, Exp. Date 10/31/2023; R2200515, Exp. Date 4/30/2025; R2200514, Exp. Date 4/30/2025; R2200516, Exp. Date 4/30/2025;  b) R2200310, Exp Date 9/30/2023; R2101354, Exp. Date 10/31/2023; R2200513, Exp. Date 4/30/2025; R2200768, Exp. Date 5/31/2025;",
      "more_code_info": ""
    }
  ]
}