Scandonest 3% Plain Injection, Solution
FDA Recall NDC 0362-1098
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Scandonest 3% Plain (NDC 0362-1098). A significant event, classified as Class III, was initiated on Nov 20, 2020 by Septodont, Inc.. The reported reason for this action was: "Labeling: Label mix-up"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Labeling: Label mix-up
Nov 20, 2020
Dec 16, 2020
15,398 cartridges
Recall Profile & Regulatory Data
Event ID
86867
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Novocol Pharmaceutical of Canada, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. nationwide.
Termination Date
May 13, 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
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
0362-1098-90Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
