Drug product
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
D-1335-2022
Product summary
- Event
- Event 90712
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1790 kits
- Official record key
drug-enforcement:D-1335-2022
Official wording
Reason: Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of Zynrelef 400 mg/12 mg kit
Code information: Lot #: 01126739, Exp 7/31/2023
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Unknown
Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of Zynrelef 400 mg/12 mg kit