{
  "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": "Schaumburg",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA201835"
        ],
        "brand_name": [
          "METHYLPREDNISOLONE ACETATE"
        ],
        "generic_name": [
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        ],
        "manufacturer_name": [
          "Sagent Pharmaceuticals"
        ],
        "product_ndc": [
          "25021-820",
          "25021-821"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRA-ARTICULAR",
          "INTRALESIONAL",
          "INTRAMUSCULAR",
          "INTRASYNOVIAL",
          "SOFT TISSUE"
        ],
        "substance_name": [
          "METHYLPREDNISOLONE ACETATE"
        ],
        "rxcui": [
          "1358610",
          "1358617"
        ],
        "spl_id": [
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        ],
        "spl_set_id": [
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        ],
        "package_ndc": [
          "25021-820-05",
          "25021-820-10",
          "25021-821-05"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "43502P7F0P"
        ]
      },
      "product_type": "Drugs",
      "event_id": "94486",
      "recalling_firm": "Sagent Pharmaceuticals",
      "address_1": "1901 N Roselle Rd Ste 450",
      "address_2": "N/A",
      "postal_code": "60195",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0499-2024",
      "product_description": "MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1 x 10 mL Multi-Dose Vial, Rx only,  Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, Made in India. NDC: 25021-820-10",
      "product_quantity": "14,360 vials",
      "reason_for_recall": "Presence of Particulate Matter: Potential for black particulates in the drug product.",
      "recall_initiation_date": "20240425",
      "center_classification_date": "20240515",
      "report_date": "20240522",
      "code_info": "Lots 5100186, 5100187, 5100188, 5100189, Exp 01/31/2025"
    }
  ]
}