HERON THERAPEUTICS, INC.: Drug Recall

Recall #D-1335-2022 · 08/02/2022

Class III: Low Risk

Recall Details

Recall Number
D-1335-2022
Classification
Class III
Product Type
Drug
Recalling Firm
HERON THERAPEUTICS, INC.
Status
Terminated
Date Initiated
08/02/2022
Location
San Diego, CA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1790 kits

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

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

Distribution Pattern

U.S.A. Nationwide

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.