HERON THERAPEUTICS, INC. recalls Zynrelef (bupivacaine and meloxicam), 400 mg bupivacaine and 12 mg meloxicam single dose application, packaged in a kit…

Recall date

August 2, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1335-2022

FDA classification

Class III

Brand / firm

HERON THERAPEUTICS, INC.

Sold / distributed

U.S.A. Nationwide

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What 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