{
  "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": "Ongoing",
      "city": "East Windsor",
      "state": "NJ",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "ANDA211695"
        ],
        "brand_name": [
          "ACETAMINOPHEN ASPIRIN AND CAFFEINE"
        ],
        "generic_name": [
          "ACETAMINOPHEN, ASPIRIN AND CAFFEINE"
        ],
        "manufacturer_name": [
          "Aurohealth LLC"
        ],
        "product_ndc": [
          "58602-882"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ACETAMINOPHEN",
          "ASPIRIN",
          "CAFFEINE"
        ],
        "rxcui": [
          "308297"
        ],
        "spl_id": [
          "20f3adf2-9058-4420-ac3b-1da54420a1d2"
        ],
        "spl_set_id": [
          "f5465419-1453-4ccc-a517-1fdff1eb3c05"
        ],
        "package_ndc": [
          "58602-882-21",
          "58602-882-38"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000000160",
          "N0000008836",
          "M0001335",
          "N0000175722",
          "N0000175578",
          "N0000008832",
          "N0000175739",
          "N0000175729",
          "N0000175790",
          "M0023046"
        ],
        "pharm_class_moa": [
          "Cyclooxygenase Inhibitors [MoA]"
        ],
        "pharm_class_pe": [
          "Decreased Prostaglandin Production [PE]",
          "Decreased Platelet Aggregation [PE]",
          "Central Nervous System Stimulation [PE]"
        ],
        "pharm_class_cs": [
          "Anti-Inflammatory Agents, Non-Steroidal [CS]",
          "Xanthines [CS]"
        ],
        "pharm_class_epc": [
          "Nonsteroidal Anti-inflammatory Drug [EPC]",
          "Platelet Aggregation Inhibitor [EPC]",
          "Central Nervous System Stimulant [EPC]",
          "Methylxanthine [EPC]"
        ],
        "unii": [
          "362O9ITL9D",
          "R16CO5Y76E",
          "3G6A5W338E"
        ]
      },
      "product_type": "Drugs",
      "event_id": "94966",
      "recalling_firm": "Aurobindo Pharma USA Inc",
      "address_1": "279 Princeton Hightstown Rd",
      "address_2": "",
      "postal_code": "08520-1401",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "NJ, NY & PA",
      "recall_number": "D-0641-2024",
      "product_description": "Healthy Living Acetaminophen, Aspirin (NSAID) and Caffeine, tablets USP, 250 mg/250 mg/65 mg, 100-count bottles, Distributed by: Aurohealth LLC, 279 Princeton-Hightstown Road, East Windsor, NJ , Made in India, NDC 58602-882-21.",
      "product_quantity": "240 bottles",
      "reason_for_recall": "Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.",
      "recall_initiation_date": "20240711",
      "center_classification_date": "20240820",
      "report_date": "20240828",
      "code_info": "Lot#: AC2523005A, Exp 6/30/2025",
      "more_code_info": ""
    }
  ]
}