{
  "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": "Cranbury",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA071017"
        ],
        "brand_name": [
          "SULFAMETHOXAZOLE AND TRIMETHOPRIM"
        ],
        "generic_name": [
          "SULFAMETHOXAZOLE AND TRIMETHOPRIM"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
          "53489-145",
          "53489-146"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SULFAMETHOXAZOLE",
          "TRIMETHOPRIM"
        ],
        "rxcui": [
          "198334",
          "198335"
        ],
        "spl_id": [
          "31dd7abe-e7f2-10df-e063-6394a90a93e2"
        ],
        "spl_set_id": [
          "4833319a-a7b3-4bf4-bec4-6531b43182d4"
        ],
        "package_ndc": [
          "53489-145-01",
          "53489-145-05",
          "53489-146-01",
          "53489-146-05"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0353489146012",
          "0353489145015"
        ],
        "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": "79909",
      "recalling_firm": "Sun Pharmaceutical Industries, Inc.",
      "address_1": "270 Prospect Plains Rd",
      "address_2": "",
      "postal_code": "08512-3605",
      "voluntary_mandated": "",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0802-2018",
      "product_description": "Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg, Rx Only, 500-count bottle, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St., Philadelphia, PA 19124, Dist, by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 53489-146-05",
      "product_quantity": "1,908 500-count bottles",
      "reason_for_recall": "Presence of Foreign Substance:Sun Pharma is recalling one (1) lot of Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg (500 ct.)  because a foreign matter identified as polyethylene was detected in two (2) tablets.",
      "recall_initiation_date": "20180419",
      "center_classification_date": "20180511",
      "termination_date": "20190228",
      "report_date": "20180523",
      "code_info": "Lot 6848501, EXP 04/2020",
      "more_code_info": ""
    }
  ]
}