Amide Local Anesthetic, Catecholamine
Where is Articaine and Epinephrine made?
12 companies sell it under their own name. Their labels name 4 factories in Italy, Canada, Germany and France.
Italy 1Canada 1Germany 1France 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Septodont, Inc. Septocaine and Epinephrine40 mg per 1 mL / 0.005 mg per 1 mL, 40 mg per 1 mL / 0.01 mg per 1 mL · NDC 0362-9048, 0362-0830, 0362-9049 | Novocol Pharmaceutical of Canada, Inc.Makes it | Cambridge, Canada | Problems found, fixed voluntarilyMay 2024 |
| Septodont Ou Septodont Sas Ou Specialites SeptodontMakes it | Saint Maur Des Fosses, France | Problems found, fixed voluntarilyMay 2023 | |
| Aira LLC5 ug per 1 mL / 40 mg per 1 mL, 10 ug per 1 mL / 40 mg per 1 mL · NDC 87566-110, 87566-112 | Pierrel SpaMakes it | Capua, Italy | Problems found, fixed voluntarilyMar 2023 |
| Benco Dental40 mg per 1 mL / 0.005 mg per 1 mL, 40 mg per 1 mL / 0.01 mg per 1 mL · NDC 66975-418, 66975-417 | Novocol Pharmaceutical of Canada, Inc.Makes it | Cambridge, Canada | Problems found, fixed voluntarilyMay 2024 |
| Burkhart Dental Supply Co., Inc5 ug per 1 mL / 40 mg per 1 mL, 10 ug per 1 mL / 40 mg per 1 mL · NDC 43498-816, 43498-993 | Pierrel SpaMakes it | Capua, Italy | Problems found, fixed voluntarilyMar 2023 |
| Dentsply Pharmaceutical Inc.40 mg per 1 mL / 0.005 mg per 1 mL, 40 mg per 1 mL / 0.01 mg per 1 mL · NDC 66312-602, 66312-601 | Novocol Pharmaceutical of Canada, Inc.Makes it | Cambridge, Canada | Problems found, fixed voluntarilyMay 2024 |
| HANSAmed, Inc.40 mg per 1 mL / 0.009 mg per 1 mL, 40 mg per 1 mL / 0.018 mg per 1 mL · NDC 52120-200, 52120-100 | Sanofi-Aventis Deutschland GmbHMakes it | Frankfurt am Main, Germany | Problems found, fixed voluntarilyMar 2022 |
| Henry Schein, Inc.40 mg per 1 mL / 0.005 mg per 1 mL, 40 mg per 1 mL / 0.01 mg per 1 mL · NDC 0404-6625, 0404-6620 | Novocol Pharmaceutical of Canada, Inc.Makes it | Cambridge, Canada | Problems found, fixed voluntarilyMay 2024 |
| NDC, Inc.40 mg per 1 mL / 0.005 mg per 1 mL, 40 mg per 1 mL / 0.01 mg per 1 mL · NDC 43128-102, 43128-101 | Novocol Pharmaceutical of Canada, Inc.Makes it | Cambridge, Canada | Problems found, fixed voluntarilyMay 2024 |
| Novocol Pharmaceutical of Canada, Inc.40 mg per 1 mL / 0.005 mg per 1 mL, 40 mg per 1 mL / 0.01 mg per 1 mL · NDC 51004-6625, 51004-4185, 51004-0102 +4 | Novocol Pharmaceutical of Canada, Inc.Makes it | Cambridge, Canada | Problems found, fixed voluntarilyMay 2024 |
| Patterson Dental Supply, Inc.40 mg per 1 mL / 0.005 mg per 1 mL, 40 mg per 1 mL / 0.01 mg per 1 mL · NDC 50227-1050, 50227-1040 | Novocol Pharmaceutical of Canada, Inc.Makes it | Cambridge, Canada | Problems found, fixed voluntarilyMay 2024 |
| Safco Dental Supply Co.5 ug per 1 mL / 40 mg per 1 mL, 10 ug per 1 mL / 40 mg per 1 mL · NDC 67239-0209, 67239-0210 | Pierrel SpaMakes it | Capua, Italy | Problems found, fixed voluntarilyMar 2023 |
| Pierrel S.p.A. Orabloc5 ug per 1 mL / 40 mg per 1 mL, 10 ug per 1 mL / 40 mg per 1 mL · NDC 45146-110, 45146-120 | The label doesn't name the factory. Plants this company names for other drugs | ||
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 …
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.