NDC 66312-602
Articadent 40 mg per 1 mL / 0.005 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
- May 2, 2019 · Class II · Septodont Inc.
Labeling: Not Elsewhere Classified. This recall has been initiated due to mislabeling. The printed carton used in manufacturing both batches contained text for both 2% Xylocaine DENTAL and Articadent DENTAL. Xylocaine DENTAL is a trade name for Lidocaine HCL 2% and Epinephrine 1: 100,000 formulation, while Articadent DENTAL is a trade name for Articaine HCI 4% and Epinephrine 1 :100,000. The cartridges contained within the printed carton are labeled appropriately as Articadent DENTAL.
Lots: Lot # D02599A, exp. Sept 2020, D02608B, exp. October 2020
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Articaine and Epinephrine: every company that makes it
- Form
- injection, solution, submucosal
- Strength
- 40 mg per 1 mL / 0.005 mg per 1 mL
- Approval
- NDA authorized generic NDA020971
- On the market since
- Sep 1, 2009
- Package NDCs
66312-602-16- Official label
- DailyMed (National Library of Medicine), updated Mar 1, 2024
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