{
  "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": "Warren",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA215395"
        ],
        "brand_name": [
          "LANREOTIDE ACETATE"
        ],
        "generic_name": [
          "LANREOTIDE ACETATE"
        ],
        "manufacturer_name": [
          "Cipla USA Inc."
        ],
        "product_ndc": [
          "69097-870",
          "69097-880",
          "69097-890"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "LANREOTIDE ACETATE"
        ],
        "rxcui": [
          "749811",
          "749814",
          "749817"
        ],
        "spl_id": [
          "fd205110-15eb-4707-82b2-185e5bbf616b"
        ],
        "spl_set_id": [
          "11da176a-99bc-4ada-8b3f-6bd2b37a6313"
        ],
        "package_ndc": [
          "69097-880-67",
          "69097-890-67",
          "69097-870-67"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "IEU56G3J9C"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98247",
      "recalling_firm": "Cipla USA, Inc.",
      "address_1": "10 Independence Blvd",
      "address_2": "",
      "postal_code": "07059-2730",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0290-2026",
      "product_description": "Lanreotide Injection, 120 mg/0.5 mL, 0.5 mL per pre-filled syringe, For deep subcutaneous injection, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059.  NDC:  69097-870-67",
      "product_quantity": "15,221 syringes",
      "reason_for_recall": "Presence of Particulate Matter.",
      "recall_initiation_date": "20260102",
      "center_classification_date": "20260115",
      "report_date": "20260121",
      "code_info": "Lot, expiry:   4301954IR1 , exp  31/10/2026 ;  4301994IR1 , exp  31/10/2026 ;  4301995IR1 , exp  31/10/2026 ;  4301996IR1 , exp  31/10/2026 ;  4400005IR1 , exp  30/11/2026 ;  4400006IR1 , exp  30/11/2026 ;  4400007IR1 , exp  30/11/2026 ;  4400124IR1 , exp  30/11/2026 ;  4400154IR1 , exp  30/11/2026 ;  4400155IR1 , exp  30/11/2026 ;  4400156IR1 , exp  30/11/2026 ;  4400373IR1 , exp  31/12/2026 ;  4400374IR1 , exp  31/12/2026 ;  4400375IR1 , exp  31/12/2026 ;  4400455IR1 , exp  31/1/2027 ;  4400456IR1 , exp  31/1/2027 ;  4400457IR1 , exp  31/1/2027 ;  4400544IR1 , exp  28/2/2027 ;  4400606IR1 , exp  28/2/2027 ;  4400607IR1 , exp  28/2/2027 ;  4400696IR1 , exp  28/2/2027 ;  4400697IR1 , exp  28/2/2027 ;  4400779IR1 , exp  28/2/2027 ;  4400780IR1 , exp  28/2/2027 ;  4400781IR1 , exp  28/2/2027 ;  4400844IR1 , exp  31/3/2027 ;  4400845IR1 , exp  31/3/2027 ;  4400849IR1 , exp  31/3/2027 ;  4400984IR1 , exp  31/3/2027 ;  4400985RIR , exp  31/3/2027 ;  4400986IR1 , exp  31/3/2027 ;  4401023IR1 , exp  31/3/2027 ;",
      "more_code_info": ""
    }
  ]
}