The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0127-2021·Announced 2020-12-16

Novocol Recalls Scandonest 3% Plain Due to Labeling Mix-Up

Novocol Pharmaceutical is recalling 15,398 cartridges of Scandonest 3% Plain (Mepivacaine Hydrochloride) due to a label mix-up. The product is distributed nationwide.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The specific hazard is a labeling mix-up, which falls under the 'Low' severity criteria for documentation or packaging issues.

Plain-English summary

Novocol Pharmaceutical of Canada, Inc. is recalling 15,398 cartridges of Scandonest 3% Plain (Mepivacaine Hydrochloride 3% without Vasoconstrictor). The recall is being conducted due to a labeling issue described as a label mix-up. The product is a prescription-only dental anesthetic packaged in cartons of 50 cartridges.

The affected product is manufactured for SEPTODONT, Inc. and distributed nationwide in the United States. The recall covers specific batches with expiration dates ranging from January 2021 to February 2022, including batch numbers D03050E, D03032F, D02983D, D02865C, D02894G, D02701G, and D02766E.

The U.S. Food and Drug Administration has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. Consumers and healthcare providers should check their inventory for the specific batch numbers and expiration dates listed in the recall notice.

The recalled product

Product
SCANDONEST 3% PLAIN (MEPIVACAINE HYDROCHLORIDE)
Brand
SCANDONEST 3% PLAIN
Manufacturer
Novocol Pharmaceutical of Canada, Inc.
Category
Drug — Dental Anesthetic
Hazard
Affected units
15,398

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (13)

  • 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

UPCs (1)

  • 0000001070354

Distribution

Distributed nationwide across the United States.

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