FDA-Drug2020-12-16Class III
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
Novocol Pharmaceutical of Canada, Inc.
Hazard
Labeling: Label mix-up
Sold states
U.S. nationwide.
Affected count
15,398 cartridges
Manufactured in
25 Wolseley Crt, N/A, Cambridge, N/A, Canada
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0127-2021Don't want to check this manually?
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