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.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0127-2021%22
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