NDC 66312-441
Polocaine 30 mg per 1 mL injection, solution
On the label: Dentsply Pharmaceutical Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Novocol Pharmaceutical of Canada, Inc. | Cambridge, Canada | Makes it | Problems found, fixed voluntarilyMay 3, 2024 · 11 inspections |
Recalls
- Oct 31, 2025 · Class II · Novocol Pharmaceutical of Canada, Inc.
Defective container: cracked/broken cartridges
Lots: Lot: D05159C, expires: 07-31-2027
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Mepivacaine: every company that makes it
- Form
- injection, solution, submucosal
- Strength
- 30 mg per 1 mL
- Approval
- ANDA ANDA088387
- On the market since
- Oct 10, 1984
- Package NDCs
66312-441-16- Official label
- DailyMed (National Library of Medicine), updated Feb 21, 2024
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