Amide Local Anesthetic, Nonsteroidal Anti-inflammatory Drug
Where is Bupivacaine and Meloxicam made?
1 company sell it under their own name. Their labels name 3 factories in India, Sweden and the United States.
India 1Sweden 1United States 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Heron Therapeutics, Inc. Zynrelef6 mg per 7 mL / 200 mg per 7 mL, 9 mg per 10.5 mL / 300 mg per 10.5 mL, 12 mg per 14 mL / 400 mg per 14 mL, 60 mg per 2.3 mL / 1.8 mg per 2.3 mL · NDC 47426-301, 47426-501, 47426-303 +5 | Apitoria Pharma Private LimitedMakes the active ingredient | Sangareddy, India | Problems found, fixed voluntarilySep 2024 |
| Cambrex Karlskoga ABMakes the active ingredient | Karlskoga, Sweden | Problems found, fixed voluntarilyMay 2024 | |
| Lifecore Biomedical, LLCMakes it | Chaska, MN, United States | Problems found, fixed voluntarilyMar 2025 |
Recalls
- Aug 2, 2022 · Class III · Heron Therapeutics, Inc.
Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of Zynrelef 400 mg/12 mg kit
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.