Zynrelef Solution
FDA Recall NDC 47426-503
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Zynrelef (NDC 47426-503). A significant event, classified as Class III, was initiated on Aug 02, 2022 by Heron Therapeutics, Inc.. The reported reason for this action was: "Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of Zynrelef 400 mg/12 mg kit"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of Zynrelef 400 mg/12 mg kit
Aug 02, 2022
Aug 24, 2022
1790 kits
Recall Profile & Regulatory Data
Event ID
90712
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
HERON THERAPEUTICS, INC.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S.A. Nationwide
Termination Date
Sep 29, 2023
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
Batch or Lot Expiration Information
Lot# : 01126739, Exp 7/31/2023
Affected Packages Involved in this Recall
47426-301-06Product
47426-301-04Product
47426-301-02Product
47426-302-06Product
47426-302-04Product
47426-302-02Product
47426-303-05Product
47426-303-03Product
47426-303-01Product
47426-304-05Product
47426-304-03Product
47426-304-01Product
47426-501-04Product
47426-501-02Product
47426-502-04Product
47426-502-02Product
47426-503-03Product
47426-503-01Product
47426-504-03Product
47426-504-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
