Zynrelef (bupivacaine and meloxicam), 400 mg bupivacaine and 12 mg meloxicam single dose application, packaged in a kit,
Summary
The FDA issued a Class III for Zynrelef (bupivacaine and meloxicam), 400 mg bupivacaine and 12 mg meloxicam sin by HERON THERAPEUTICS, INC.. Reason: Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of Zynrelef 400 mg/12 mg kit.
Details
Source
Drug Recall
External ID
D-1335-2022
Action Date
2022-08-24
Status
Terminated
Category
drug
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
Lot/Code Info: Lot #: 01126739, Exp 7/31/2023
Quantity Affected: 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
Distribution
U.S.A. Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2022-08-02
Company
San Diego, CA
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 61 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (HERON THERAPEUTICS, INC.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does HERON THERAPEUTICS, INC. have FDA actions?
This is the only FDA action we have on record for HERON THERAPEUTICS, INC. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1335-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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