{
  "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": "2026-06-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Parsippany",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA210317"
        ],
        "brand_name": [
          "OCTREOTIDE ACETATE"
        ],
        "generic_name": [
          "OCTREOTIDE ACETATE"
        ],
        "manufacturer_name": [
          "Teva Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "0480-9257",
          "0480-9259",
          "0480-9262"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR"
        ],
        "rxcui": [
          "898589",
          "898601",
          "898605"
        ],
        "spl_id": [
          "2e77a034-b0ae-4694-8ac0-ae1319754d3a"
        ],
        "spl_set_id": [
          "d9739ea6-74de-4a41-a806-6e827a23cedb"
        ],
        "package_ndc": [
          "0480-9257-08",
          "0480-9256-01",
          "0480-9263-21",
          "0480-9259-08",
          "0480-9258-01",
          "0480-9262-08",
          "0480-9260-01"
        ],
        "is_original_packager": [
          true
        ]
      },
      "product_type": "Drugs",
      "event_id": "98609",
      "recalling_firm": "Teva Pharmaceuticals USA, Inc",
      "address_1": "400 Interpace Pkwy Bldg A",
      "address_2": "",
      "postal_code": "07054-1120",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0406-2026",
      "product_description": "Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, Single-dose 8 mL vial in Kit, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054, NDC 0480-9262-08.",
      "product_quantity": "21,930 Cartons",
      "reason_for_recall": "Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.",
      "recall_initiation_date": "20260317",
      "center_classification_date": "20260327",
      "report_date": "20260401",
      "code_info": "Lot:4400401, Exp.: 6/30/2026; 4401393, 4401494, 4401604, Exp.: 9/31/2026; 4500564, 4500601, 4500707, 4500796, 4500859, 4500918, 4500919, 4501006, Exp.: 3/31/2027.",
      "more_code_info": ""
    }
  ]
}