Recalls / Class III
Class IIID-1335-2022
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
- Brand name
- Zynrelef
- Generic name
- Bupivacaine And Meloxicam
- Active ingredients
- Bupivacaine, Meloxicam
- Route
- Infiltration
- NDCs
- 47426-301, 47426-302, 47426-303, 47426-304, 47426-501, 47426-502, 47426-503, 47426-504
- FDA application
- NDA211988
- Affected lot / code info
- Lot #: 01126739, Exp 7/31/2023
Why it was recalled
Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of Zynrelef 400 mg/12 mg kit
Recalling firm
- Firm
- HERON THERAPEUTICS, INC.
- Manufacturer
- Heron Therapeutics, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4242 Campus Point Ct Ste 200, San Diego, California 92121-1513
Distribution
- Quantity
- 1790 kits
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2022-08-02
- FDA classified
- 2022-08-12
- Posted by FDA
- 2022-08-24
- Terminated
- 2023-09-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1335-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.