CLASS III Drug recall · Reported 16 Dec 2020 · FDA Enforcement Report
Scandonest 3% Plain (Mepivacaine Hydrochloride 3% without recalled
Novocol Pharmaceutical of Canada is recalling Scandonest 3% Plain (Mepivacaine Hydrochloride 3% without Vasoconstrictor), distributed nationwide in the US. The recall was initiated on 20 Nov 2020 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0127-2021
- FDA event ID
- 86867
- Recalling firm
- Novocol Pharmaceutical of Canada, Cambridge, N/A
- Brand
- Scandonest 3% Plain
- Manufacturer
- Septodont, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 20 Nov 2020
- FDA classified
- 9 Dec 2020
- Reported
- 16 Dec 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
Timeline
| 20 Nov 2020 | Recall initiated by company | |
| 9 Dec 2020 | Classified by FDA | +19 days |
| 16 Dec 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Label mix-up
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Scandonest 3% Plain (Mepivacaine Hydrochloride 3% without Vasoconstrictor), packaged in cartons of 50 cartridges (1.7 mL each), Rx only, Manufactured for SEPTODONT, Inc., Louisville, CO 80027, by Novocol Pharmaceutical of Canada, Inc., Cambridge, ON N1R 6X3, Canada, NDC 0362-1098-90
Where it was distributed
U.S. nationwide.
Questions about this recall
Why was it recalled?
Labeling: Label mix-up
Which lots are affected?
Batch # D03050E, D03032F, Exp 28-Feb-2022; D02983D, Exp 30-Nov-2021; D02865C, Exp 31-Aug-2021; D02894G, Exp 30-Sep-2021; D02701G, Exp 31-Jan-2021; D02766E, Exp 30-Apr-2021
Where was it sold?
U.S. nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Novocol Pharmaceutical of Canada
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Lidocaine HCI 2% and Epinephrine 1:100 recalledLidocaine | Novocol Pharmaceutical of Canada | Packaging Defects | Nationwide |
| Drug | CLASS II | Cook-Walte, Carbocaine 3% (30 mg/mL) recalledCarbocaine | Novocol Pharmaceutical of Canada | Packaging Defects | Nationwide |
| Drug | CLASS II | OraVerse, (Phentolamine Mesylate) Injection, 0.4 mg recalledOraverse | Novocol Pharmaceutical of Canada | Packaging Defects | Nationwide |
| Drug | CLASS II | 2% Xylocaine Dental with Epinephrine 1:100 recalledXylocaine | Novocol Pharmaceutical of Canada | Packaging Defects | Nationwide |
| Drug | CLASS II | 3% Polocaine Dental, Mepivacaine Hydrochloride 3% (30mg/mL) recalledPolocaine | Novocol Pharmaceutical of Canada | Packaging Defects | Nationwide |
Other Mepivacaine recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Cook-Walte, Carbocaine 3% (30 mg/mL) recalledCarbocaine | Novocol Pharmaceutical of Canada | Packaging Defects | Nationwide |
| Drug | CLASS II | 3% Polocaine Dental, Mepivacaine Hydrochloride 3% (30mg/mL) recalledPolocaine | Novocol Pharmaceutical of Canada | Packaging Defects | Nationwide |
| Drug | CLASS II | darby dental supply, Mepivacaine, Mepivacaine HCI recalledMepivacaine | Novocol Pharmaceutical of Canada | Packaging Defects | Nationwide |
| Drug | CLASS II | Benco dental Graham Chemical CO., Mepivacaine HCI recalledMepivacaine | Novocol Pharmaceutical of Canada | Packaging Defects | Nationwide |
| Drug | CLASS II | Mepivacaine HCL/epinephrine recalled by Franck's Lab Inc., d.b.a. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Sterility | Nationwide |