BUPIVACAINE Recall D-1335-2022
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
BUPIVACAINE Recall D-1335-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1335-2022 |
| Event ID | 90712 |
| Brand | ZYNRELEF |
| Generic Name | BUPIVACAINE AND MELOXICAM |
| Manufacturer | BUPIVACAINE AND MELOXICAM |
| Original Package? | 1 |
| Active Substance | BUPIVACAINE MELOXICAM |
| Drug Route | INFILTRATION |
| Distribution | U.S.A. Nationwide |
| Quantity | 1790 kits |
| Recall Reason | Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of Zynrelef 400 mg/12 mg kit |
| Drug Classification | Class III |
| Drug Code Info | 20220824 |
| Product NDC | 47426-301 47426-302 47426-303 |
| Product NUI | N0000175682 M0000897 N0000175976 |
| Pharma Class (PE) | Local Anesthesia [PE] |
| Pharma Class (EPC) | Amide Local Anesthetic [EPC] |
| Pharma Class (CS) | Amides [CS] |
| Recall Initiation Date | 20220802 |
| Report Date | 20220824 |
| Classification Date | 20220812 |
| Address | 4242 Campus Point Ct Ste 200 San Diego, CA 92121-1513 United States |
| Recalling Firm | HERON THERAPEUTICS, INC. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | Y8335394RO VG2QF83CGL |
| Drug Application Number | NDA211988 |
| Structured Product Labeling (SPL ID) | db910158-178b-4186-b853-7ded7f0d5fdb |
| Structured Product Labeling (SPL Set ID) | dab484a7-9353-43ba-9e74-7fab910c712b |
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