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
Reported: August 24, 2022 Initiated: August 2, 2022 #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
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
Details
- Recalling Firm
- HERON THERAPEUTICS, INC.
- Units Affected
- 1790 kits
- Distribution
- U.S.A. Nationwide
- Location
- San Diego, CA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by HERON THERAPEUTICS, INC.. Units affected: 1790 kits.
Why was this product recalled? ▼
Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of Zynrelef 400 mg/12 mg kit
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 24, 2022. Severity: Low. Recall number: D-1335-2022.
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