November 2020 FDA Recall Scandonest 3% Plain by Novocol Pharmaceutical Of Canada, Inc.
D-0127-2021 - Labeling

This Class III drug recall was voluntarily initiated by Novocol Pharmaceutical Of Canada, Inc. on November 20, 2020 for the product Scandonest 3% Plain. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0127-2021

Reason for Recall
Labeling: Label mix-up
Initiated
11-20-2020
Reported
12-16-2020
Quantity
15,398 cartridges

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86867
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Novocol Pharmaceutical of Canada, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-13-2021
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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

Affected Packages Involved in this Recall

0362-1098-90 Scandonest 3% Plain