{
  "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": "2026-07-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "San Diego",
      "state": "CA",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA211988"
        ],
        "brand_name": [
          "ZYNRELEF"
        ],
        "generic_name": [
          "BUPIVACAINE AND MELOXICAM"
        ],
        "manufacturer_name": [
          "Heron Therapeutics, Inc."
        ],
        "product_ndc": [
          "47426-501",
          "47426-301",
          "47426-302",
          "47426-303",
          "47426-304",
          "47426-502",
          "47426-503",
          "47426-504"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INFILTRATION"
        ],
        "substance_name": [
          "BUPIVACAINE",
          "MELOXICAM"
        ],
        "rxcui": [
          "2560306",
          "2560308",
          "2560309",
          "2560311",
          "2560312",
          "2560315",
          "2560319",
          "2560321"
        ],
        "spl_id": [
          "ab2a0921-41d7-4b3b-ace9-6adccb12c5e9"
        ],
        "spl_set_id": [
          "dab484a7-9353-43ba-9e74-7fab910c712b"
        ],
        "package_ndc": [
          "47426-301-06",
          "47426-301-04",
          "47426-301-02",
          "47426-302-06",
          "47426-302-04",
          "47426-302-02",
          "47426-303-05",
          "47426-303-03",
          "47426-303-01",
          "47426-304-05",
          "47426-304-03",
          "47426-304-01",
          "47426-501-04",
          "47426-501-02",
          "47426-502-04",
          "47426-502-02",
          "47426-503-03",
          "47426-503-01",
          "47426-504-03",
          "47426-504-01"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000000160",
          "M0001335",
          "N0000175722",
          "N0000175682",
          "M0000897",
          "N0000175976"
        ],
        "pharm_class_moa": [
          "Cyclooxygenase Inhibitors [MoA]"
        ],
        "pharm_class_cs": [
          "Anti-Inflammatory Agents, Non-Steroidal [CS]",
          "Amides [CS]"
        ],
        "pharm_class_epc": [
          "Nonsteroidal Anti-inflammatory Drug [EPC]",
          "Amide Local Anesthetic [EPC]"
        ],
        "pharm_class_pe": [
          "Local Anesthesia [PE]"
        ],
        "unii": [
          "VG2QF83CGL",
          "Y8335394RO"
        ]
      },
      "product_type": "Drugs",
      "event_id": "90712",
      "recalling_firm": "HERON THERAPEUTICS, INC.",
      "address_1": "4242 Campus Point Ct Ste 200",
      "address_2": "",
      "postal_code": "92121-1513",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S.A. Nationwide",
      "recall_number": "D-1335-2022",
      "product_description": "Zynrelef (bupivacaine and meloxicam), 400 mg bupivacaine and 12 mg meloxicam single dose application, packaged in a kit, Rx only, Manufactured for Heron Therapeutics, Inc., San Diego, CA, NDC 47426-301-02",
      "product_quantity": "1790 kits",
      "reason_for_recall": "Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of Zynrelef 400 mg/12 mg kit",
      "recall_initiation_date": "20220802",
      "center_classification_date": "20220812",
      "termination_date": "20230929",
      "report_date": "20220824",
      "code_info": "Lot #: 01126739, Exp 7/31/2023",
      "more_code_info": ""
    }
  ]
}