{
  "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": "San Diego",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA208845"
        ],
        "brand_name": [
          "ZILRETTA"
        ],
        "generic_name": [
          "TRIAMCINOLONE ACETONIDE EXTENDED-RELEASE INJECTABLE SUSPENSION"
        ],
        "manufacturer_name": [
          "Pacira Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "65250-003"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRA-ARTICULAR"
        ],
        "rxcui": [
          "1947131",
          "1947133"
        ],
        "spl_id": [
          "9806c4e8-2b5d-4e6b-915b-60426d912fb3"
        ],
        "spl_set_id": [
          "cd5c4673-21f2-4126-9556-da847b3a228b"
        ],
        "package_ndc": [
          "65250-003-01",
          "65250-001-01",
          "65250-002-01"
        ],
        "is_original_packager": [
          true
        ]
      },
      "product_type": "Drugs",
      "event_id": "94791",
      "recalling_firm": "PACIRA PHARMACEUTICALS INC",
      "address_1": "10578 Science Center Dr",
      "address_2": "",
      "postal_code": "92121-1143",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide.",
      "recall_number": "D-0567-2024",
      "product_description": "Zilretta (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Manufactured for: Pacira Pharmaceuticals Inc., San Diego, CA 92121, NDC 65250-003-01 (carton) NDC 65250-001-01 (vial) with Diluent 5 mL Sterile single-use vial, Rx Only, Mfd. for: Pacira Pharmaceuticals, Inc. NDC 65250-002-01",
      "product_quantity": "40,517 kits",
      "reason_for_recall": "Failed Dissolution Specifications  - did not meet the acceptance criteria for IVR Level 3 testing at 9 months 2-8¿C followed by 6 weeks at 25¿C",
      "recall_initiation_date": "20240612",
      "center_classification_date": "20240625",
      "report_date": "20240703",
      "code_info": "Lot 23-9006; Expiry Date: MAR 2025",
      "more_code_info": ""
    }
  ]
}