{
  "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": "Terminated",
      "city": "Greenville",
      "state": "SC",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA203621"
        ],
        "brand_name": [
          "NYSTATIN"
        ],
        "generic_name": [
          "NYSTATIN"
        ],
        "manufacturer_name": [
          "PAI Holdings, LLC dba PAI Pharma"
        ],
        "product_ndc": [
          "0121-0868"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "NYSTATIN"
        ],
        "spl_id": [
          "7d265612-edc5-42bc-8e58-bae7d7ab7918"
        ],
        "spl_set_id": [
          "28b4e26e-206a-4e8a-abfe-774b780e91c3"
        ],
        "package_ndc": [
          "0121-0868-02",
          "0121-0868-16",
          "0121-0868-05",
          "0121-0868-40",
          "0121-0868-50",
          "0121-0868-00"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0301210868160",
          "0301210868023"
        ],
        "nui": [
          "N0000175498",
          "M0017172"
        ],
        "pharm_class_epc": [
          "Polyene Antifungal [EPC]"
        ],
        "pharm_class_cs": [
          "Polyenes [CS]"
        ],
        "unii": [
          "BDF1O1C72E"
        ]
      },
      "product_type": "Drugs",
      "event_id": "88392",
      "recalling_firm": "PAI Holdings, LLC. dba Pharmaceutical Associates Inc",
      "address_1": "1700 Perimeter Rd",
      "address_2": "N/A",
      "postal_code": "29605-5252",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distributed Nationwide in the USA",
      "recall_number": "D-0721-2021",
      "product_description": "Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, Rx ONLY,  packaged in a) 16 fl oz (473 mL) NDC 0121-0868-16; b) 2 fl oz (60 mL) NDC 0121-0868-02; Manufactured by: Pharmaceutical Associates, Inc. Greenville, SC 29605",
      "product_quantity": "a) 1002 cases (12 bottles/case); b) 458 cases (24 bottles/case)",
      "reason_for_recall": "Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.",
      "recall_initiation_date": "20210729",
      "center_classification_date": "20210812",
      "termination_date": "20221202",
      "report_date": "20210818",
      "code_info": "Lots: a) C98F, C990 Exp. 30SEP2022, C9C2 Exp. 31OCT2022; b) C9E1 Exp. 31OCT2022"
    }
  ]
}