{
  "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,
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    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Mahwah",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA218311"
        ],
        "brand_name": [
          "ACETAMINOPHEN, IBUPROFEN"
        ],
        "generic_name": [
          "ACETAMINOPHEN, IBUPROFEN"
        ],
        "manufacturer_name": [
          "GLENMARK THERAPEUTICS INC., USA"
        ],
        "product_ndc": [
          "72657-157"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "IBUPROFEN",
          "ACETAMINOPHEN"
        ],
        "rxcui": [
          "2387532"
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        "spl_id": [
          "b3d8d869-735e-4720-8b2b-a3eacc92041f"
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        "package_ndc": [
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          "72657-157-36",
          "72657-157-72",
          "72657-157-74",
          "72657-157-76",
          "72657-157-20",
          "72657-157-05"
        ],
        "is_original_packager": [
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        ],
        "upc": [
          "0372657157742"
        ],
        "nui": [
          "N0000000160",
          "M0001335",
          "N0000175722"
        ],
        "pharm_class_moa": [
          "Cyclooxygenase Inhibitors [MoA]"
        ],
        "pharm_class_cs": [
          "Anti-Inflammatory Agents, Non-Steroidal [CS]"
        ],
        "pharm_class_epc": [
          "Nonsteroidal Anti-inflammatory Drug [EPC]"
        ],
        "unii": [
          "WK2XYI10QM",
          "362O9ITL9D"
        ]
      },
      "product_type": "Drugs",
      "event_id": "96474",
      "recalling_firm": "Glenmark Pharmaceuticals Inc., USA",
      "address_1": "750 Corporate Dr",
      "address_2": "N/A",
      "postal_code": "07430-2009",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S. Nationwide",
      "recall_number": "D-0347-2025",
      "product_description": "Acetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/125 mg a). 144-count packets (NDC# 72657-157-74), b). 216-count packets( 72657-157-76),Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ 07430, Product of India",
      "product_quantity": "N/A",
      "reason_for_recall": "CGMP Deviations",
      "recall_initiation_date": "20250313",
      "center_classification_date": "20250408",
      "report_date": "20250416",
      "code_info": "Lot #  17241302, exp. date Jul-26 Amazon & Walmart 17241140, exp. date Jul-26 Amazon & Walmart 17241141, exp. date Jul-26 Amazon & Walmart"
    }
  ]
}