FDA recall D-0127-2021

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 for recall

Labeling: Label mix-up

Distribution

U.S. nationwide.

Key facts

Status

Terminated

Initiation date

2020-11-20

Report date

2020-12-16

Termination date

2021-05-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cambridge, N/A, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0127-2021