Novocol Pharmaceutical of Canada, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 9
- 510(k) Clearances
- 0
- Inspections
- 10
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0228-2026 | Class II | 2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packag | October 31, 2025 |
| D-0234-2026 | Class II | OraVerse, (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a carton containing 10 cartri | October 31, 2025 |
| D-0230-2026 | Class II | 3% Polocaine DENTAL, Mepivacaine Hydrochloride 3% (30mg/mL) (Mepivacaine HCI Injection, USP), packag | October 31, 2025 |
| D-0233-2026 | Class II | Cook-Walte, Carbocaine 3% (30 mg/mL), (mepivacaine hydrochloride Injection, USP), packaged in a cart | October 31, 2025 |
| D-0232-2026 | Class II | Benco dental Graham CHEMICAL CO., Mepivacaine HCI 3% (30 mg/mL) Injection, [Mepivacaine HCI Injectio | October 31, 2025 |
| D-0229-2026 | Class II | Lidocaine HCI 2% and Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged i | October 31, 2025 |
| D-0231-2026 | Class II | darby dental supply, MEPIVACAINE, Mepivacaine HCI 3% (30mg/mL) Injection, [Mepivacaine HCI Injection | October 31, 2025 |
| D-0127-2021 | Class III | Scandonest 3% Plain (Mepivacaine Hydrochloride 3% without Vasoconstrictor), packaged in cartons of 5 | November 20, 2020 |
| D-923-2013 | Class II | Lidocaine Hydrochloride 2% and Epinephrine 1:100,000 Injection, Rx Only, For Dental Block and Infilt | August 14, 2013 |