{
  "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": "2026-09-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Jadcherla, Mahabubnagar District",
      "state": "",
      "country": "India",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA215179"
        ],
        "brand_name": [
          "PEMRYDI RTU"
        ],
        "generic_name": [
          "PEMETREXED DISODIUM"
        ],
        "manufacturer_name": [
          "Amneal Pharmaceuticals LLC"
        ],
        "product_ndc": [
          "70121-2453",
          "70121-2461",
          "70121-2462"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "PEMETREXED DISODIUM HEMIPENTAHYDRATE"
        ],
        "rxcui": [
          "2637958",
          "2637964",
          "2637966",
          "2637967",
          "2637968",
          "2637969"
        ],
        "spl_id": [
          "b6a00be1-95d1-4b91-93bf-4430a57eeff6"
        ],
        "spl_set_id": [
          "0f006b06-ab85-423d-ba0c-dfc3fc25844e"
        ],
        "package_ndc": [
          "70121-2453-1",
          "70121-2461-1",
          "70121-2462-1"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0370121246213",
          "0370121246114",
          "0370121245315"
        ],
        "unii": [
          "F4GSH45R4C"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99530",
      "recalling_firm": "Shilpa Medicare Limited",
      "address_1": "Plot No. S20 to S26, Pharmaceutical Formulations SEZ",
      "address_2": "TSIIC Green Industrial Park, Polepally (Village)",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA.",
      "recall_number": "D-0765-2026",
      "product_description": "PEMRYDI RTU(pemetrexed injection), 500 mg/50 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedabad, India; Distributed by: Amneal Pharmaceuticals LC, Bridgewater, NY 08807.  NDC: 70121-2461-1",
      "product_quantity": "9,489 50mL vials",
      "reason_for_recall": "Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials",
      "recall_initiation_date": "20260729",
      "center_classification_date": "20260814",
      "report_date": "20260826",
      "code_info": "Lot: P400157, Exp 08/31/2026; Lot PA00047A, Exp 09/30/2027",
      "more_code_info": ""
    }
  ]
}