{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Lewis Center",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA076899"
        ],
        "brand_name": [
          "SULFAMETHOXAZOLE AND TRIMETHOPRIM"
        ],
        "generic_name": [
          "SULFAMETHOXAZOLE AND TRIMETHOPRIM"
        ],
        "manufacturer_name": [
          "Amneal Pharmaceuticals of New York LLC"
        ],
        "product_ndc": [
          "53746-271",
          "53746-272"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SULFAMETHOXAZOLE",
          "TRIMETHOPRIM"
        ],
        "rxcui": [
          "198334",
          "198335"
        ],
        "spl_id": [
          "bc5fe496-071b-4c25-95da-14c6c561e79e"
        ],
        "spl_set_id": [
          "3233c54d-484d-4550-b172-db8af47d1b7f"
        ],
        "package_ndc": [
          "53746-271-50",
          "53746-271-01",
          "53746-271-05",
          "53746-271-10",
          "53746-272-11",
          "53746-272-24",
          "53746-272-01",
          "53746-272-02",
          "53746-272-05"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0353746271013",
          "0353746272010"
        ],
        "nui": [
          "N0000175504",
          "M0020790",
          "N0000185504",
          "N0000175489",
          "N0000000191",
          "N0000187062",
          "N0000187061"
        ],
        "pharm_class_epc": [
          "Sulfonamide Antimicrobial [EPC]",
          "Dihydrofolate Reductase Inhibitor Antibacterial [EPC]"
        ],
        "pharm_class_cs": [
          "Sulfonamides [CS]"
        ],
        "pharm_class_moa": [
          "Cytochrome P450 2C9 Inhibitors [MoA]",
          "Dihydrofolate Reductase Inhibitors [MoA]",
          "Cytochrome P450 2C8 Inhibitors [MoA]",
          "Organic Cation Transporter 2 Inhibitors [MoA]"
        ],
        "unii": [
          "JE42381TNV",
          "AN164J8Y0X"
        ]
      },
      "product_type": "Drugs",
      "event_id": "64611",
      "recalling_firm": "Shamrock Medical Solutions Group LLC",
      "address_1": "741 Radio Dr",
      "address_2": "",
      "postal_code": "43035-7134",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Telephone",
      "distribution_pattern": "Product was shipped to the following states: CO, MA, OH, TX & WY.",
      "recall_number": "D-1450-2014",
      "product_description": "Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg, DOUBLE STRENGTH, Rx, packaged and labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg, Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfg: Amneal/Interpharm, NDC 53746-272-01",
      "product_quantity": "284/800 mg tablets",
      "reason_for_recall": "Labeling: Label Mix up; product labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg instead of Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg",
      "recall_initiation_date": "20110927",
      "center_classification_date": "20140723",
      "termination_date": "20140731",
      "report_date": "20140730",
      "code_info": "Lot 00288N, Use By: 9/15/2012, NDC 53746-272-01",
      "more_code_info": ""
    }
  ]
}