FDA Drug recall D-0127-2021
Scandonest 3% Plain (Mepivacaine Hydrochloride 3% without Vasoconstrictor), packaged in cartons of 50 cartridges (1.7 mL each), Rx only, Ma…
- FDA Drug
- Class III
- terminated
- Published 2020-12-16
On 2020-12-16 the FDA classified a Class III recall of Scandonest 3% Plain (Mepivacaine Hydrochloride 3% without Vasoconstrictor), packaged in cartons of 50 cartridges (1.7 mL each), Rx only, Ma… by Novocol Pharmaceutical, citing labeling: Label mix-up.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0127-2021 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2020-11-20 |
| Published | 2020-12-16 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Novocol Pharmaceutical |
| Distribution | US |
Product
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
Reason
Labeling: Label mix-up
Identifiers
| ndc | 0362-1098-90 |
|---|---|
| code_info | Batch # D03050E, D03032F, Exp 28-Feb-2022; D02983D, Exp 30-Nov-2021; D02865C, Exp 31-Aug-2021; D02894G, Exp 30-Sep-2021…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 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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FDA Drug · Class II · 2025-12-24 · Novocol Pharmaceutical - OraVerse, (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a carton containing 10 cartridges, 0.4 mg/1.7mL, Rx only, Made in Ca…
FDA Drug · Class II · 2025-12-24 · Novocol Pharmaceutical - darby dental supply, MEPIVACAINE, Mepivacaine HCI 3% (30mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containing…
FDA Drug · Class II · 2025-12-24 · Novocol Pharmaceutical
All Novocol Pharmaceutical recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0127-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.