{
  "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": "East Windsor",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA090624"
        ],
        "brand_name": [
          "SULFAMETHOXAZOLE AND TRIMETHOPRIM"
        ],
        "generic_name": [
          "SULFAMETHOXAZOLE AND TRIMETHOPRIM"
        ],
        "manufacturer_name": [
          "Aurobindo Pharma Limited"
        ],
        "product_ndc": [
          "65862-419",
          "65862-420"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SULFAMETHOXAZOLE",
          "TRIMETHOPRIM"
        ],
        "rxcui": [
          "198334",
          "198335"
        ],
        "spl_id": [
          "e4ea8e99-58d4-4c1b-b84c-db0838610059"
        ],
        "spl_set_id": [
          "284b5dac-2b8d-46bf-95fe-80ce03fa178a"
        ],
        "package_ndc": [
          "65862-419-20",
          "65862-419-01",
          "65862-419-05",
          "65862-419-99",
          "65862-420-20",
          "65862-420-01",
          "65862-420-05",
          "65862-420-99"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175489",
          "N0000000191",
          "N0000187062",
          "N0000187061",
          "N0000175504",
          "M0020790",
          "N0000185504"
        ],
        "pharm_class_epc": [
          "Dihydrofolate Reductase Inhibitor Antibacterial [EPC]",
          "Sulfonamide Antimicrobial [EPC]"
        ],
        "pharm_class_moa": [
          "Dihydrofolate Reductase Inhibitors [MoA]",
          "Cytochrome P450 2C8 Inhibitors [MoA]",
          "Organic Cation Transporter 2 Inhibitors [MoA]",
          "Cytochrome P450 2C9 Inhibitors [MoA]"
        ],
        "pharm_class_cs": [
          "Sulfonamides [CS]"
        ],
        "unii": [
          "AN164J8Y0X",
          "JE42381TNV"
        ]
      },
      "product_type": "Drugs",
      "event_id": "88227",
      "recalling_firm": "Aurobindo Pharma USA Inc.",
      "address_1": "279 Princeton Hightstown Rd",
      "address_2": "N/A",
      "postal_code": "08520-1401",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "N/A",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0719-2021",
      "product_description": "Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg Double Strength, 500 Tablets,  Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-HIghtstown Road, EAs Windsor, NJ 08520, Made in India, NDC 65862-420-05",
      "product_quantity": "3800 bottles",
      "reason_for_recall": "Presence of Foreign Substance- Potential of metal contamination.",
      "recall_initiation_date": "20210707",
      "center_classification_date": "20210810",
      "termination_date": "20231018",
      "report_date": "20210818",
      "code_info": "Batch SP1D19082AA3 &  Batch SP1D19085AA3; Exp 08/2022"
    }
  ]
}