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BUPIVACAINE Recall D-1335-2022

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

BUPIVACAINE Recall D-1335-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1335-2022
Event ID90712
BrandZYNRELEF
Generic NameBUPIVACAINE AND MELOXICAM
ManufacturerBUPIVACAINE AND MELOXICAM
Original Package?1
Active SubstanceBUPIVACAINE MELOXICAM
Drug RouteINFILTRATION
DistributionU.S.A. Nationwide
Quantity1790 kits
Recall ReasonDefective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of Zynrelef 400 mg/12 mg kit
Drug ClassificationClass III
Drug Code Info20220824
Product NDC47426-301 47426-302 47426-303
Product NUIN0000175682 M0000897 N0000175976
Pharma Class (PE)Local Anesthesia [PE]
Pharma Class (EPC)Amide Local Anesthetic [EPC]
Pharma Class (CS)Amides [CS]
Recall Initiation Date20220802
Report Date20220824
Classification Date20220812
Address4242 Campus Point Ct Ste 200
San Diego, CA 92121-1513
United States
Recalling FirmHERON THERAPEUTICS, INC.
Initial Notification Letter
Unique Ingredient IdentifierY8335394RO VG2QF83CGL
Drug Application NumberNDA211988
Structured Product Labeling (SPL ID)db910158-178b-4186-b853-7ded7f0d5fdb
Structured Product Labeling (SPL Set ID)dab484a7-9353-43ba-9e74-7fab910c712b
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