{
  "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": "Siddipet (District)",
      "state": "",
      "country": "India",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA217166"
        ],
        "brand_name": [
          "KETOROLAC TROMETHAMINE"
        ],
        "generic_name": [
          "KETOROLAC TROMETHAMINE"
        ],
        "manufacturer_name": [
          "Camber Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "31722-305",
          "31722-306",
          "31722-307"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS"
        ],
        "substance_name": [
          "KETOROLAC TROMETHAMINE"
        ],
        "rxcui": [
          "860092",
          "1665459",
          "1665461"
        ],
        "spl_id": [
          "23a5daec-e083-eec0-e063-6394a90a2411"
        ],
        "spl_set_id": [
          "478aff0b-29fd-43b2-a701-5236b8f8e3df"
        ],
        "package_ndc": [
          "31722-305-25",
          "31722-305-10",
          "31722-306-25",
          "31722-307-25",
          "31722-307-02"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "4EVE5946BQ"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97711",
      "recalling_firm": "Aspiro Pharma Limited",
      "address_1": "Survey No. 321, Biotech Park, Phase Iii",
      "address_2": "Karkapatla Village, Markook (Mandal)",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0036-2026",
      "product_description": "Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL Single-Dose Vial, For Intramuscular Use Only, Rx only, Mfd. for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Mfd. by: ASPIRO PHARMA LIMITED, Telangana - 502281, INDIA., U.S. Contact Number: 1-866-495-1995, NDC 31722-307-25 (Carton), 31722-307-02 (Vial label).",
      "product_quantity": "",
      "reason_for_recall": "Presence of Particulate Matter: Particulate matter identified as glass",
      "recall_initiation_date": "20251001",
      "center_classification_date": "20251021",
      "report_date": "20251029",
      "code_info": "Lot #: AS1240347A, Exp Date 09/2026; AS1240144A, Exp Date 05/2026; AS1240145A, AS1240146A, Exp Date 06/2026; AS1250295A, Exp Date 05/2027.",
      "more_code_info": ""
    }
  ]
}