FDA-Drug2022-08-24Class III

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

HERON THERAPEUTICS, INC.
Hazard

Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of Zynrelef 400 mg/12 mg kit

Sold states
U.S.A. Nationwide
Affected count
1790 kits
Manufactured in
4242 Campus Point Ct Ste 200, San Diego, CA, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1335-2022

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