D-1335-2022 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 24, 2022
- Initiation Date
- August 2, 2022
- Termination Date
- September 29, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1790 kits
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
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 Pattern
U.S.A. Nationwide
Code Information
Lot #: 01126739, Exp 7/31/2023