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
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 numbers, UPCs & expiration codes
Lot #: 01126739, Exp 7/31/2023
Where it was sold
U.S.A. Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1335-2022
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 2, 2022
- FDA report date
- Aug 24, 2022
- Quantity
- 1790 kits
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- HERON THERAPEUTICS, INC.
Original FDA data
Every field from FDA enforcement report D-1335-2022, exactly as published.
Show all FDA fields
- City
- San Diego
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 90712
- Address
- 4242 Campus Point Ct Ste 200
- Code information
- Lot #: 01126739, Exp 7/31/2023
- Postal code
- 92121-1513
- Report date
- Aug 24, 2022
- Product type
- Drugs
- Recall number
- D-1335-2022
- Classification
- Class III
- Recalling firm
- HERON THERAPEUTICS, INC.
- Product quantity
- 1790 kits
- Termination date
- Sep 29, 2023
- 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
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- U.S.A. Nationwide
- Recall initiation date
- Aug 2, 2022
- Initial firm notification
- Letter
- Center classification date
- Aug 12, 2022