{
  "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 III",
      "openfda": {
        "application_number": [
          "ANDA074091"
        ],
        "brand_name": [
          "LOPERAMIDE HYDROCHLORIDE"
        ],
        "generic_name": [
          "LOPERAMIDE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Discount Drug Mart"
        ],
        "product_ndc": [
          "53943-123"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "LOPERAMIDE HYDROCHLORIDE"
        ],
        "rxcui": [
          "978010"
        ],
        "spl_id": [
          "0ea718d4-6b56-b9ee-e063-6294a90a8111"
        ],
        "spl_set_id": [
          "6bc9771d-09f8-47ce-bbbd-8dd9aae97693"
        ],
        "package_ndc": [
          "53943-123-12",
          "53943-123-24"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "77TI35393C"
        ],
        "upc": [
          "093351112706"
        ]
      },
      "product_type": "Drugs",
      "event_id": "81893",
      "recalling_firm": "Sun Pharmaceutical Industries, Inc.",
      "address_1": "270 Prospect Plains Rd",
      "address_2": "N/A",
      "postal_code": "08512-3605",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "OH",
      "recall_number": "D-0391-2019",
      "product_description": "LOPERAMIDE HCL TABLETS USP, 2 mg, ANTI-DIARRHEAL,  24 caplets per carton, OTC, Distributed by Drug Mart-Food Fair Medina Ohio 44256  Ohm Laboratories Inc. UPC 0 93351 11270 6 NDC#:53943-123-24",
      "product_quantity": "5040 cartons",
      "reason_for_recall": "Labeling Not Elsewhere Classified:  The front panel indicates 24 caplets whereas the side panel indicates 12 caplets. The drug product carton contains 24 caplets.",
      "recall_initiation_date": "20181226",
      "center_classification_date": "20190123",
      "termination_date": "20200402",
      "report_date": "20190130",
      "code_info": "Lot: 2979325, EXP 5/5021"
    }
  ]
}