{
  "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": "Completed",
      "city": "Bridgewater",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA021849"
        ],
        "brand_name": [
          "OMEPRAZOLE AND SODIUM BICARBONATE"
        ],
        "generic_name": [
          "OMEPRAZOLE, SODIUM BICARBONATE"
        ],
        "manufacturer_name": [
          "Oceanside Pharmaceuticals"
        ],
        "product_ndc": [
          "68682-102",
          "68682-990",
          "68682-991",
          "68682-104"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "OMEPRAZOLE",
          "SODIUM BICARBONATE"
        ],
        "rxcui": [
          "616539",
          "616541",
          "753557",
          "753562"
        ],
        "spl_id": [
          "342c0d17-867e-d8da-e063-6394a90a3151"
        ],
        "spl_set_id": [
          "c26b6893-8264-4d4a-ac7e-1ddda933451e"
        ],
        "package_ndc": [
          "68682-990-30",
          "68682-991-30",
          "68682-102-30",
          "68682-104-30"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368682102307",
          "0368682104301"
        ],
        "nui": [
          "N0000175525",
          "N0000000147",
          "N0000182140"
        ],
        "pharm_class_epc": [
          "Proton Pump Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "Proton Pump Inhibitors [MoA]",
          "Cytochrome P450 2C19 Inhibitors [MoA]"
        ],
        "unii": [
          "KG60484QX9",
          "8MDF5V39QO"
        ]
      },
      "product_type": "Drugs",
      "event_id": "93911",
      "recalling_firm": "Bausch Health Companies, Inc.",
      "address_1": "400 Somerset Corporate Blvd",
      "address_2": "",
      "postal_code": "08807-2867",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0355-2024",
      "product_description": "Omeprazole and Sodium Bicarbonate For Oral Suspension  40mg/1,680mg, This packet contains 40mg of omeprazole and 1,680mg of sodium bicarbonate, Directions for Use: Empty packet contents into a small cup containing 1 to 2 tablespoons of WATER. DO NOT USE OTHER LIQUIDS OR FOODS. Stir well and drink immediately. Rx Only, Distributed by: Oceanside Pharmaceuticals, a division of Bausch Health US, LLC, Bridgewater, NJ 08807, NDC 68682-991-30.",
      "product_quantity": "3,600 cartons",
      "reason_for_recall": "Subpotent Drug: Out of specification for assay",
      "recall_initiation_date": "20240202",
      "center_classification_date": "20240228",
      "report_date": "20240306",
      "code_info": "Lot #0013R; Exp. 01/2026",
      "more_code_info": ""
    }
  ]
}