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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Novocol Pharmaceutical of Canada, Inc.: Scandonest 3% Plain (Mepivacaine HCl) Recalled for Label Mix-up

Agency Publication Date: December 9, 2020
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Summary

Novocol Pharmaceutical of Canada, Inc. is recalling 15,398 cartridges of Scandonest 3% Plain (mepivacaine hydrochloride 3% without vasoconstrictor), a dental anesthetic. The recall was initiated because of a label mix-up, where the cartridges or packaging may be incorrectly identified. Because this medication is used as an injectable anesthetic for dental procedures, a labeling error could lead to the administration of the wrong drug or incorrect dosage. Consumers and dental professionals should contact their healthcare provider or pharmacist regarding this voluntary recall.

Risk

A label mix-up can result in a patient receiving the incorrect medication or concentration of anesthetic, which may lead to inadequate pain management or unexpected side effects during dental procedures.

What You Should Do

  1. Check your dental supply inventory for Scandonest 3% Plain (Mepivacaine Hydrochloride 3% without Vasoconstrictor) in cartons of 50 cartridges (1.7 mL each) with NDC 0362-1098-90.
  2. Verify if your product matches the affected Batch numbers and Expiration dates: D03050E (Exp 28-Feb-2022), 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), or D02766E (Exp 30-Apr-2021).
  3. Immediately stop using any cartridges from the affected batches and set them aside to prevent accidental use.
  4. Contact your healthcare provider or pharmacist for guidance, and return any unused product to the place of purchase for a refund.
  5. Contact Novocol Pharmaceutical of Canada, Inc. or the distributor, Septodont, Inc., for further instructions regarding the return of the affected product.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Refund for unused dental anesthetic cartridges.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund.

Affected Products

Product: Scandonest 3% Plain (Mepivacaine Hydrochloride 3% without Vasoconstrictor) (1.7 mL cartridges)
Model:
NDC 0362-1098-90
Lot Numbers:
Batch D03050E (Exp 28-Feb-2022)
Batch D03032F (Exp 28-Feb-2022)
Batch D02983D (Exp 30-Nov-2021)
Batch D02865C (Exp 31-Aug-2021)
Batch D02894G (Exp 30-Sep-2021)
Batch D02701G (Exp 31-Jan-2021)
Batch D02766E (Exp 30-Apr-2021)
Date Ranges: Exp 28-Feb-2022, Exp 30-Nov-2021, Exp 31-Aug-2021, Exp 30-Sep-2021, Exp 31-Jan-2021, Exp 30-Apr-2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 86867
Status: Resolved
Manufacturer: Novocol Pharmaceutical of Canada, Inc.
Sold By: SEPTODONT, Inc.
Manufactured In: Canada
Units Affected: 15,398 cartridges
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.