{
  "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": "94568",
      "recalling_firm": "PACIRA PHARMACEUTICALS INC",
      "address_1": "10578 Science Center Dr",
      "address_2": "N/A",
      "postal_code": "92121-1143",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S. Nationwide.",
      "recall_number": "D-0546-2024",
      "product_description": "Drug Vial Label: Zilretta¿ (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Manufactured for: Pacira Pharmaceuticals Inc., San Diego, CA 92121, NDC 65250-001-01.  Diluent Vial Label: Diluent, 5mL, Sterile single use, Rx only, Manufactured for Pacira Pharmaceuticals Inc., NDC 65250-002-01.  Carton Label: Drug Vial Label: 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.",
      "product_quantity": "43,768 kits",
      "reason_for_recall": "Failed Stability Specifications - at 12 months 2-8 degrees C followed by 6 weeks at 25 degrees C.",
      "recall_initiation_date": "20240507",
      "center_classification_date": "20240607",
      "report_date": "20240619",
      "code_info": "Lot: 082657 (kit 23-9004), Exp: July 2024."
    }
  ]
}