{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Hyderabad",
      "state": "N/A",
      "country": "India",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA200895"
        ],
        "brand_name": [
          "SIMVASTATIN"
        ],
        "generic_name": [
          "SIMVASTATIN"
        ],
        "manufacturer_name": [
          "Camber Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "31722-510",
          "31722-511",
          "31722-512",
          "31722-513",
          "31722-514"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SIMVASTATIN"
        ],
        "rxcui": [
          "198211",
          "200345",
          "312961",
          "312962",
          "314231"
        ],
        "spl_id": [
          "1553d57f-414d-2c66-e063-6294a90af8e0"
        ],
        "spl_set_id": [
          "751b79c6-bba8-4d29-b69c-a2ac6453fec8"
        ],
        "package_ndc": [
          "31722-510-30",
          "31722-510-01",
          "31722-510-10",
          "31722-510-90",
          "31722-511-30",
          "31722-511-01",
          "31722-511-10",
          "31722-511-90",
          "31722-512-30",
          "31722-512-01",
          "31722-512-10",
          "31722-512-90",
          "31722-513-30",
          "31722-513-01",
          "31722-513-10",
          "31722-513-90",
          "31722-514-30",
          "31722-514-01",
          "31722-514-05",
          "31722-514-90"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0331722511308",
          "0331722510301"
        ],
        "nui": [
          "N0000175589",
          "N0000000121"
        ],
        "pharm_class_epc": [
          "HMG-CoA Reductase Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"
        ],
        "unii": [
          "AGG2FN16EV"
        ]
      },
      "product_type": "Drugs",
      "event_id": "78821",
      "recalling_firm": "Hetero Labs, Ltd. - Unit III",
      "address_1": "Plot 22-110, Part Ii, Ida",
      "address_2": "Rangareddy, Jeedimetla",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S.A. nationwide",
      "recall_number": "D-0223-2018",
      "product_description": "Simvastatin Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured by: Hetero (trademark), Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India, NDC 31722-513-10",
      "product_quantity": "N/A",
      "reason_for_recall": "Presence of foreign substance: metallic razor blade was found in one bottle.",
      "recall_initiation_date": "20171222",
      "center_classification_date": "20180116",
      "termination_date": "20180323",
      "report_date": "20180124",
      "code_info": "Lot #: E171280, Exp 06/19"
    }
  ]
}