Drug recall D-0127-2021

Class III Terminated reported Dec 16, 2020

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

Lots and codes

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

Recall details

Recalling firm
Novocol Pharmaceutical of Canada, Inc., Cambridge, N/A
Quantity
15,398 cartridges
Distribution
U.S. nationwide.
Type
Voluntary: Firm initiated
Recall initiated
November 20, 2020
Terminated
May 13, 2021

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