FDA Drug recall D-1335-2022
Zynrelef (bupivacaine and meloxicam), 400 mg bupivacaine and 12 mg meloxicam single dose application, packaged in a kit, Rx only, Manufactu…
- FDA Drug
- Class III
- terminated
- Published 2022-08-24
On 2022-08-24 the FDA classified a Class III recall of Zynrelef (bupivacaine and meloxicam), 400 mg bupivacaine and 12 mg meloxicam single dose application, packaged in a kit, Rx only, Manufactu… by Heron Therapeutics, citing defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of Zynrelef 400 mg/12 mg kit.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1335-2022 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2022-08-02 |
| Published | 2022-08-24 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Heron Therapeutics |
| Distribution | US |
Product
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
Reason
Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of Zynrelef 400 mg/12 mg kit
Identifiers
| ndc | 47426-301-06 |
|---|---|
| ndc | 47426-301-04 |
| ndc | 47426-301-02 |
| ndc | 47426-302-06 |
| ndc | 47426-302-04 |
| ndc | 47426-302-02 |
| ndc | 47426-303-05 |
| ndc | 47426-303-03 |
| ndc | 47426-303-01 |
| ndc | 47426-304-05 |
| ndc | 47426-304-03 |
| ndc | 47426-304-01 |
| ndc | 47426-501-04 |
| ndc | 47426-501-02 |
| ndc | 47426-502-04 |
| ndc | 47426-502-02 |
| ndc | 47426-503-03 |
| ndc | 47426-503-01 |
| ndc | 47426-504-03 |
| ndc | 47426-504-01 |
| code_info | Lot #: 01126739, Exp 7/31/2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1335-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.