PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: December 16, 2020 Initiated: November 20, 2020 #D-0127-2021

Product Description

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

Details

Units Affected
15,398 cartridges
Distribution
U.S. nationwide.
Location
Cambridge, N/A

Frequently Asked Questions

What product was recalled?
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. Recalled by Novocol Pharmaceutical of Canada, Inc.. Units affected: 15,398 cartridges.
Why was this product recalled?
Labeling: Label mix-up
Which agency issued this recall?
This recall was issued by the FDA Drug on December 16, 2020. Severity: Low. Recall number: D-0127-2021.